Unapproved uses: The Food and Drug Administration wants input on whether it needs to revise the rules governing manufacturers, packers and distributors' communications about unapproved uses of approved medical products.
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"We believe the unapproved use of medicines for purely economic reasons breaches established laws governing the unapproved or unlicensed use of medicines," according to a statement from the Basel-based company.
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It's with unapproved outsourcing to factories we don't know about.
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"Unregistered or unlicensed medical products" are untested and unapproved drugs.
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"Health care professionals generally may choose to prescribe or use a legally marketed human drug for an unapproved use when they judge that the unapproved use is medically appropriate," the agency said in a statement.
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The freeze was lifted in December, but Tencent's games remained unapproved.
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Cockroach Corner is the source of tons of suspected unapproved parts.
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And the selling of kits, it seems, would be considered illegal because, in broad terms, the agency would consider it the sale of any unapproved "gene therapy product" akin to the sale of an unapproved drug.
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The promo was unapproved and CMA removed it prior to the broadcast.
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The number of calls, however, is much lower than other unapproved substances.
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A plan to encourage early voting in Florida went unapproved for weeks.
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If the rules say you can't keep your casino afloat with an unapproved loan and you respond to that by getting a shady secret unapproved loan to keep your casino afloat, shouldn't you be out of the casino game?
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According to the lawsuit, Korovin, a celebrity throat doctor, performed the unapproved laryngoscopies.
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Only a handful of doctors have faced prosecution for buying foreign, unapproved Botox.
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Another unapproved minority is the Mosuo, a matriarchal group of around 40,000 people.
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But, of course, many of these procedures are unapproved because they are dangerous.
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Products still unapproved by August 8th 2019 must be pulled from store shelves.
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But the use of unapproved testing methods appears to have been long prevalent.
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But doctors can, and often do, prescribe medications for unapproved "off-label" indications.
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Until then, the FDA considers the hand sanitizers to be unapproved drug products.
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Johnson started the race in the back because of an unapproved gear change.
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More than one unapproved pharmaceutical ingredient was found in 20% of those supplements.
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It is illegal for pharmaceutical salespeople to tout a medication for unapproved uses.
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An unapproved new drug has not been approved for use by the FDA.
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Not so Uber, which amended its bylaws in 2013 to restrict unapproved secondary sales.
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They flew together over another backyard, this one with an unapproved garden in it.
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Children as young as a seven-day-old infant received the unapproved oral vaccines.
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Daniel Suarez had to start in the back because of an unapproved tire change.
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The FDA also told the company that its Nanotainer was an unapproved medical device.
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As a result, the department was awash in unapproved products purchased without requisite approvals.
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The presence of the drugs makes Euphoric an unapproved drug, according to a release.
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In October, the FDA ruled that the company's nanotainers were an "unapproved" medical device.
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Transdev told NHTSA that it would stop the "unapproved operations," according to the agency.
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Most of the products sold online as SARMs contain either these unapproved substances alone -- sometimes in amounts different from what is specified on the label -- or other unapproved hormones and steroids, according to a study published Tuesday in the medical journal JAMA.
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"Using unapproved prescription drugs for personal use is a potentially dangerous practice," the spokesperson said.
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Austin Dillon and Paul Menard started in the back after unapproved adjustments to their cars.
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Previously, the league handed out $25,000 fines for posting unapproved video (including GIFs) during games.
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Also, check your credit score, bank and credit card statements for unapproved accounts and transactions.
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And in 2013 the state drugs controller listed e-cigarettes and vaporizers as "unapproved drugs".
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Honor killings — women killed by male relatives for contact with an unapproved male — still occur.
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"If an unapproved variety got into the supply chain, it would be catastrophic," Sutter said.
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China banned initial coin offerings last week as an unapproved and illegal form of public financing.
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The agency has justified its seize-and-burn policy by classifying kratom products as unapproved drugs.
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Johnson started the race in the back, despite qualifying 14th, because of an unapproved body modification.
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It also subsidises "cost-effective and essential" drugs; unapproved drugs, if available, can be prohibitively expensive.
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The FDA has already sent warning letters to seven companies hawking the treatment for unapproved purposes.
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Unapproved drugs may harm or even kill patients when their side effects haven't been widely tested.
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Officials have warned that anyone conducting unapproved interviews could face prosecution under Thailand's child protection laws.
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Doctors are permitted to practice medicine as they see fit, including prescribing drugs for unapproved uses.
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Unapproved nominations are typically returned to the president at the end of each session of Congress.
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These applications, similar to right-to-try laws, also offer patients access to unapproved medical products.
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She was promoting a bill that she said would allow unapproved treatments for people with terminal illnesses.
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In recent years, the agency has been waging an offensive against clinics offering unapproved stem cell therapies.
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Other studies have also found traces of unapproved substances in brands purchased after a recall was lifted.
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"There are no assurances that unapproved products from foreign sources are safe or effective," the FDA said.
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Regular observation and enforcement was the only way to prevent unapproved propagation, unlicensed seeding, and independent fertilization.
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The article is worth checking out for the screenshot of the unapproved porn apps' ridiculous icons alone.
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FDA Commissioner Scott Gottlieb then issued a public statement reaffirming the agency's intent to regulate unapproved treatments.
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So, too, does the man credited with developing the system, which blocks access to unapproved foreign websites.
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The details: The so-called "right to try" bill would let terminally ill patients buy unapproved treatments.
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Seoul bans the entry of unapproved GMOs, defined as living modified organisms (LMO) under bio safety regulations.
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The F.D.A. said the injunction "sends a strong message to others" who manufacture unapproved stem cell products.
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If the FDA doesn't object to a patient taking the unapproved drug, the patient can do so.
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Patients will have to provide informed consent in writing before obtaining an unapproved drug under the bill.
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To hold Europeans' data in an unapproved state, firms and customers must set up special legal structures.
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Federal law bars importing unapproved prescription drugs into the United States, although millions of Americans do so.
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"We've been very active in combating illegal online sales of unapproved medicine," an agency spokesperson told Vox.
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In 2016, Mill was placed under 90 days of house arrest for violating probation due to unapproved travel.
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The NFL announced recently that it would fine teams for posting "unapproved video" on social media during games.
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" Didi is making facial recognition "compulsory" for drivers on Hitch to "minimize the risk of unapproved account use.
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In October, the FDA ruled that nanotainers the company created to collect blood were an "unapproved" medical device.
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In 2016, Mill was placed under house arrest for 90 days for violating probation due to unapproved travel.
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Some states allow insurers to deny hospice or home healthcare benefits if a patient uses an unapproved drug.
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Lopera applied the unapproved technique on Farmer for more than a minute, according to a police department statement.
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Virginia is now one of thirty states allowing drug companies to give unapproved drugs to terminally ill patients.
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The largest settlement, totaling $90 million, resolves allegations the drugmaker encouraged doctors to use Seroquel for unapproved uses.
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Source3 could potentially help brands and creators identify unapproved appearances of their content or IP through Rights Manager.
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But this is of little matter to a patient who experiences a dramatic remission from an unapproved drug.
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It was engineers at Nissan who discovered that Mitsubishi was using unapproved mileage tests that exaggerated fuel performance.
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Since Beijing classifies "DeTiaoGang" as illegal, unapproved capacity, it does not count towards the official capacity cut targets.
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The agency proposed the penalty over the installation of unapproved equipment in the 737 Max and other aircraft.
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Lack of government action spurred underground networks like the Dallas Buyers Club, which supplied people with unapproved drugs.
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Much speculation centers on an unapproved drug, AICAR, which helps an athlete lose weight without losing muscle mass.
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The agency said it was reclassifying Purell as an unapproved drug, rather than an over-the-counter product.
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The warning letter requested that CanaRx immediately stop selling unapproved new drugs from foreign sources to American buyers.
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After the discovery of bogus Avastin, OCI initially focused on tracking down doctors who purchased foreign unapproved cancer medications.
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The FAA did not concur with Shi's allegations that NHJ used unapproved substitute material to make parts for Moog.
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But the FDA is calling out clinics that are offering unapproved, untested treatments, some of which have blinded patients.
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An FDA expert once testified he didn't learn how to identify foreign unapproved labels until he joined the agency.
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Instead, unapproved third-party delivery services had filled that gap by picking up bulk orders for their own customers.
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FRANKFURT (Reuters) - U.S. authorities have found three unapproved software programs in 3.0 liter diesel engines made by Volkswagen's (VOWG_p.
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Biotech seed makers seek approval from importers before launching new products because countries can reject shipments of unapproved varieties.
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The Florida-based long-distance carrier had also added unapproved charges to consumers' phone bills, according to the FCC.
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And because the companies are making health claims about their products, they're essentially selling kratom as an unapproved drug.
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But he kept violating his probation — first, in 2016, for unapproved travel (which caused a 90-day house arrest).
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Drug makers are even subject to criminal prosecution and civil liability if they discuss unapproved uses of existing drugs.
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All patients who improve while taking investigational drugs during clinical trials are benefitting from the use of unapproved drugs.
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But the FDA has yet to issue additional warnings about pediatric use, and unapproved uses of the drugs persist.
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The Deloitte report also found "a number of in-use but unapproved credit models" in November during its review.
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The federal and state governments last year warned seed distributors and farmers against planting and selling the unapproved variety.
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Her paperwork, however, remains unapproved by the Office of Government Ethics, an issue Democrats will be certain to bring up.
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If someone wants to test an unapproved drug in humans, they must first clear a clinical investigation with the FDA.
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The FDA noted that the cannabis claims are part of a larger uptick in unapproved products claiming to treat cancer.
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A drug is deemed foreign unapproved if it is manufactured without FDA oversight or lacks labels approved by the agency.
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Monsanto has said local seed companies have illegally attempted to "incorporate unauthorized and unapproved herbicide-tolerant technologies into their seeds".
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These pharmacies often don't require a valid prescription to purchase drugs, which may be unapproved, expired, counterfeit, or otherwise unsafe.
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The company also advised people to maintain "good physical control" over their monitors and avoid linking them to unapproved devices.
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Marketed and labeled as dietary supplements, the products are actually unapproved drugs no evaluated for safety, according to the FDA.
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"Uses beyond those contained in the approved label are considered unapproved uses," company spokesman Morry Smulevitz said in an email.
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A spokeswoman for the Food and Drug Administration said it was illegal to import unapproved drugs into the United States.
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While SARMs are advertised as supplements, the FDA statement explains that they are actually drugs—and unapproved ones at that.
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Earlier in the press conference, Fauci was undercut by Trump on whether an unapproved treatment for COVID-19 was safe.
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The treatments cost thousands of dollars, and most patients pay out of pocket because insurers refuse to cover unapproved therapies.
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Mr. Hugin's former company, Celgene, recently settled a $280 million lawsuit claiming that it marketed cancer drugs for unapproved uses.
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Since our babies were born last summer, I've been busy overriding all of my dog-tested-and-unapproved parental instincts.
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California has the biggest share of unapproved backlogged air quality plans, with 130 out of 350 total, EPA officials said.
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Leaving nothing to chance, Moscow's electoral commission found bogus reasons to disqualify all unapproved candidates from running in the elections.
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In the overwhelming majority of cases (97%), the unapproved pharmaceutical ingredients were not declared on the labels of the supplements.
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He said the agency should "protect the American public from the fraudulent and unapproved medical claims" made by the company.
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The FDA also cited accounts of patients being given experimental, unapproved treatments for diseases like arthritis, stroke, multiple sclerosis, and diabetes.
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Investigators say the driver lost control of the bus while driving down an unapproved route at well over the speed limit.
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"The public health risks of unapproved drugs from foreign sources outweigh any potential cost savings," the FDA said in a statement.
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One seller and proponent of black salve, Greg Caton, was arrested in 2004 for violating FDA rules about selling unapproved drugs.
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Officials say 332 people were pardoned, most of them convicted and imprisoned for breaking a controversial law that prohibits unapproved demonstrations.
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The FDA's Office of Criminal Investigations (OCI) is responsible for launching criminal probes into counterfeit, adulterated and mislabeled and unapproved drugs.
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Ty Dillon wound up in the back after his qualifying attempt on Friday was disallowed because of an unapproved body modification.
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In April, Mitsubishi admitted using unapproved mileage tests on cars it sells in Japan, which exaggerated the vehicles' stated fuel performance.
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For example, under the compassionate use clause, the FDA allows patients access to unapproved drugs that are still undergoing clinical trials.
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The naira hit 497 per dollar on the unapproved open retail market on Friday, weaker than its opening level of 495.
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And they've said the legislation provides "false hope" because drugmakers aren't required to give patients the unapproved drugs if they ask.
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A law enacted in 226 created the process and requirements for receiving authorization to use unapproved testing products in health emergencies.
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The agency says the company makes unapproved products from umbilical cord blood and sells them in platinum, gold and silver categories.
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A law enacted in 2004 created the process and requirements for receiving authorization to use unapproved testing products in health emergencies.
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The FDA has exercised jurisdiction over kratom as an unapproved drug, and has also taken action against kratom-containing dietary supplements.
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Pharmaceutical companies that provide unapproved drugs could also be subject to lawsuits by patients who claim to be injured by them.
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More than half the time, the study found, the FDA doesn't enforce recalls of supplements that knowingly include unapproved prescription drug ingredients.
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Most recently, several people in Nebraska developed serious infections and sepsis, a potentially life-threatening complication, after receiving unapproved stem cell products.
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Maharashtra has seized unapproved seeds worth 12 million rupees ($178,000) in the past two months, enough to cultivate 10,000 hectares, said Gholap.
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Known as the Tainted Products Marketed as Supplements List, it catalogs any time the FDA reports finding unapproved pharmaceutical ingredients in supplements.
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And I&aposll tell you, those conditions, Neil, could make an approved deal be in reality an unapproved deal, a bad deal.
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Launching Enlist widely without Beijing's approval would risk causing unapproved seeds or soybeans to be inadvertently shipped to China, the biggest importer.
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The Saudi government holds that he was killed in a physical altercation during an unapproved operation to return him to Saudi Arabia.
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"Compassionate use" of experimental drugs allows physicians to prescribe unapproved treatments for patients who have no other satisfactory alternatives in the market.
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Opponents argue it gives "false hope" to patients since drugmakers aren't required to give unapproved medicines to patients who ask for them.
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"We have found no unapproved GMO wheat on imports of distribution restriction measures we had on the U.S. wheat products," it said.
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In another recent case, controlled substances and unapproved drugs from India were mailed to patients in the U.S. for over 18 months.
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The Saudi government maintains that Khashoggi was killed during a physical altercation during an unapproved operation to return him to Saudi Arabia.
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Last year, Apple Inc dropped a number of unapproved VPN apps from its app store in China, after Beijing adopted tighter rules.
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In the meantime, vapers are being told to stay cautious of their cartridges, particularly concerning unapproved products purchased on the black market.
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Monsanto cites particles that drift in the wind when the product is sprayed improperly or when unapproved versions of dicamba are used.
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It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment.
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"Since it contains the unapproved condom imagery, we were hoping you could remove this file from the server," the government official wrote.
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But exposing American patients to potentially counterfeit, unapproved or adulterated drugs — for what would probably be scant savings — is not the answer.
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Federal health officials directed 21 websites Tuesday to stop selling what regulators say are illegal, "potentially dangerous, unapproved and misbranded" opioids online.
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In addition, The Washington Post has reported that the foundation spent money for unapproved purposes, like settling lawsuits involving Mr. Trump's businesses.
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More than one unapproved pharmaceutical ingredient was found in 2350% of those supplements, the study published Friday in JAMA Network Open showed.
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The small number of applications, and anecdotes about patients traveling to other countries to gain access to unapproved medicines, support this contention.
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Most of it is farmed from Southeast Asia, and most of those farms have bad records of using banned or unapproved antibiotics.
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But nearly all of the patients who were sickened had received the stem cells for unapproved conditions like nerve pain or joint problems.
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He also sided with the FDA in a case over whether the agency should be forced to provide access to an unapproved drug.
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"Over the years, we have kept the regulators and key stakeholders apprised of the illegal usage of unapproved technology," the Monsanto spokesman said.
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Commissioner Scott Gottlieb said the FDA remains "concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims."
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Biotech seed makers seek approval from importers such as the Philippines before launching new products because countries can reject shipments of unapproved varieties.
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"The command enjoins parents to desist from taking their children/wards to illegal, unauthorized or unapproved remand/rehabilitation centers," the police statement said.
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Stewart-Haas Racing teammates Kurt Busch and Kevin Harvick had to drop to the back at the start because of unapproved body modifications.
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"We appreciate the efforts being taken by the authorities to curb the sale of illegal and unapproved seeds," said a Monsanto India spokesman.
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A former Celgene sales manager blew the whistle and alleged in a lawsuit that Medicare and Medicaid paid for the drugs while unapproved.
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The research looked at 10 years of FDA records, and over 20% of the discovered offending products contained more than one unapproved drug.
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Why it matters: It's a clear improvement for an agency that has been under pressure to clear a backlog of unapproved drug applications.
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Congress is considering "Right to Try" (RTT) bills related to the use of unapproved medical products by patients diagnosed with a terminal illness.
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Another unapproved transaction of $300 million was made to 1MDB PetroSaudi Ltd, a joint venture company set up in the British Virgin Islands.
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For example, as far back as the 1980s, patients with AIDS achieved substantial increases in longevity through the use of unapproved antiretroviral drugs.
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Prescribing for unapproved uses is not illegal, but diagnosing a patient with a condition in order to secure Medicare coverage is considered fraud.
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Mitsubishi did not initially say how extensively it had used the unapproved methods, whether it was on all models or just a few.
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The Food and Drug Administration (FDA) is cracking down on websites marketing unapproved opioids, which could be dangerous to consumers who take them.
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He calls it "jailbreaking," similar to how you might remove Apple's software restrictions from your iPhone so that you can run unapproved apps.
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Unapproved G.M.O. food can be found elsewhere in China's food supply, said Jiajun Dale Wen, an energy and environment researcher at Renmin University.
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In 22019, the unapproved cross-dressing comedy Some Like It Hot, with its racketeering, gambling, and even homosexual undertones, was a massive hit.
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Celgene, the company that helped make him wealthy, recently settled a $250 million lawsuit claiming that it marketed cancer drugs for unapproved uses.
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In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients.
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The DEP said last month that it documented numerous environmental violations in construction, like using unapproved construction techniques and leaking fluids into waterways.
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Larson had turned a lap of 133.324 miles per hour, but his time was disallowed because of an unapproved rear deck fin lid.
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Federal prosecutors have fined a Canadian online pharmacy $34 million for importing counterfeit drugs and unapproved pharmaceuticals into the U.S., ABC News reported.
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An avid sky diver, she once parachuted secretly into an unapproved part of the city for 20 minutes of kayaking with Mr. Colwell.
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It was designed to give terminally ill patients access to unapproved medications and to provide immunity for physicians willing to administer the treatments.
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An authorization under paragraph (2202) may authorize an emergency use of a product that (A) is not approved, licensed or cleared for commercial distribution...("unapproved product") One promising unapproved "drug" that could control the vector that spreads Zika, and whose progress has been stymied by regulators, is a genetically engineered Aedes aegypti mosquito product made by Oxitec, a British company.
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Kyaw Htut, head of the western Yangon region police, said the protest organizers would face charges for holding the demonstration in an unapproved location.
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The FDA regularly screens supplement products to see if they contain unapproved pharmaceutical ingredients, which are typically added to create the product's advertised effects.
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"Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight," the FDA's letter said.
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But a design flaw allowed users to sidestep that protection through the group chat system, allowing children to enter group chats with unapproved strangers.
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A Monsanto India spokesman said the company was confident that the government would prosecute those involved in the illegal trade of the unapproved seeds.
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Farmers are paying as much as a 30 percent premium for the unapproved seeds in Maharashtra and Gujarat compared with seeds of older strains.
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Shares of Sarepta Therapeutics fell nearly 26 percent Thursday as the Food and Drug Administration finalized new procedures for expanded access for unapproved drugs.
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While Johnson contends this legislation would provide terminally ill patients with the right to try unapproved drugs, it would actually do no such thing.
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Theresa May, who became prime minister via a Tory leadership contest rather than a general election, is launching a prospectus unapproved by the electorate.
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Last fall, shipments of sodium thiopental, ordered by Texas and Arizona from an unapproved source in India, were seized in airports by federal officials.
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There are numerous examples of patients suffering with cancer or from serious infections, like HIV, who have benefited from early access to unapproved drugs.
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Still, they argued that Khashoggi was unintentionally killed during a physical altercation that resulted from an unapproved operation to return him to Saudi Arabia.
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The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.
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On Wednesday, the company said it will enforce compulsory driver facial recognition for each Didi Hitch trip to prevent unapproved use of the app.
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And these sites can look quite legitimate — a major online Canadian pharmacy recently smuggled nearly $85033 million of unapproved drugs into the United States.
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The bureau was looking at how Clinton handled classified information that passed through the unapproved private email system she used while secretary of State.
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The unapproved use of Nintendo's intellectual property can weaken our ability to protect and preserve it, or to possibly use it for new projects.
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To address such concerns, the legislation would shield drugmakers, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients.
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Mae Ferguson, a Parks Department spokeswoman, said the statue was removed because the installation of any unapproved structure is illegal in any city park.
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Some start-ups, like Kick Health, sell blood pressure pills or other prescription drugs for unapproved uses like calming the symptoms of performance anxiety.
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Another closely watched decision will be Dr. Gottlieb's response to the charged question of how broadly drug companies can market products for unapproved uses.
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Drug makers have long run so-called "compassionate use" programs that allow patients to take unapproved, experimental drugs if they have no other options.
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However, unapproved plants were found in 2018 in Alberta, Canada, in 2016 in Washington state, in 2014 in Montana and in 2013 in Oregon.
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Pudao Cottage, a highly regarded bookstore on Mao'er Hutong north of the Forbidden City, shut down after workers bricked over an unapproved glass entrance.
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FDA's track record — it allows virtually all requests to go forward — demonstrates that the agency is not an impediment to access to unapproved products.
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Jim Sutter, head of the U.S. Soybean Export Council, said he was confident Dow and ADM can keep E3 soybeans out of unapproved markets.
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Within three months, in fact, he was charged with probation violations after admitting to using an unapproved cellphone to access the app, records show.
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They note it doesn't necessarily mean patients will actually get the medicines, as drug companies aren't required to grant requests for the unapproved drugs.
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I even considered unfriending certain especially app-promiscuous friends, but, realizing this task was Sisyphean, I resigned myself to unwanted and unapproved data leaks.
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Last September the education ministry launched an inspection of school textbooks to strip out unapproved content, and re-focus education on Communist ideology and history.
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In that case, the FDA also had to rush out an unapproved test to detect the West Nile virus in the blood supply, Ziman said.
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" The FDA said in its warning letter, "the sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products.
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The Botox cases are part of a larger effort to crack down on what are known as foreign unapproved medical products - so-called "FUMP" cases.
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The order, issued by senior Andhra Pradesh official B. Rajasekhar, did not say how the farmers accessed the unapproved variety of genetically modified (GM) cotton.
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A flaw in Facebook's messaging app aimed at kids allowed thousands of users to enter group chats with unapproved strangers, The Verge reported on Monday.
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Between 2007 and 2016 nearly 800 over-the-counter dietary supplements were found to contain unapproved drug ingredients, according to a study published in October.
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Between 2007 and 2016, the FDA issued warnings about unapproved pharmaceutical ingredients in 776 dietary supplements, according to a new report in JAMA Network Open.
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Using unapproved GM strains is illegal and the state earlier said criminal charges can be brought against those found guilty under India's Environment Protection Act.
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Section 564(a)(1) says that "notwithstanding any provision of this Act," the Secretary may authorize an unapproved product even if not approved for humans.
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The FDA warned 85033 websites Tuesday that they must stop "illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications," including tramadol and oxycodone.
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The Botox cases are part of a larger effort to crack down on what are known as foreign unapproved medical products – so-called "FUMP" cases.
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According to a 2017 study published in JAMA, 39 percent of the SARMs-containing supplements contain unapproved drugs such as banned growth hormones or steroids.
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In 2013, South Korean millers suspended imports of U.S. wheat after the discovery of an unapproved strain of genetically modified wheat in the United States.
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They also contend it isn't needed, as they argue the FDA already has a process through which access to an unapproved drug can be requested.
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The House and Senate bills would establish a new pathway providing access to unapproved prescription drugs for certain patients who had exhausted other treatment options.
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"Batch after batch after batch is getting rejected for unapproved pesticides," Tree said, referring to Colorado marijuana that's newly being subjected to consumer safety tests.
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Microsoft told CBC transactions made with a parent's credit card are "legitimate" and that parents should use the safeguarding features available to prevent unapproved charges.
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But Mr. Rajoy's government warns that it will not allow the regional government to flout the Spanish Constitution by holding an unapproved referendum on independence.
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Opponents of the bill say there is a difference between dying comfortably and dying horribly, suffering pain and other side effects of an unapproved drug.
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To address such concerns, the legislation would shield drug companies, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients.
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And the industry has worse problems than misleading claims: The FDA's own data shows that unapproved prescription drugs exist in 20 percent of dietary supplements.
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In a statement Friday, Dr. Scott Gottlieb, commissioner of the US Food and Drug Administration, warned consumers to beware of "fraudulent or unapproved" flu products.
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Under India's Environment Protection Act, farmers can be imprisoned for up to five years and fined 100,000 rupees ($1,436.99) for planting any unapproved seed variety.
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Alvogen argued that Nevada prison officials obtained its product, midazolam, through "subterfuge" for unapproved purposes and that it doesn't want its midazolam, used in "botched" executions.
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The lawsuit by Minnesota Attorney General Lori Swanson alleged that the company marketed the opioid drug intended to alleviate pain in cancer patients for unapproved uses.
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Minnesota's lawsuit, filed in Hennepin County District Court, accused Insys of encouraging doctors to prescribe Subsys to people with other medical conditions and at unapproved doses.
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Parents may not be able to obtain vital household-registration papers for children with unapproved names, meaning they could be denied free schooling and health care.
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The doctor who created a genetically modified "three-parent baby" has been reprimanded by the Food and Drug Administration for aggressively marketing the unapproved experimental procedure.
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Proponents of biotech crops in China argue that commercializing GMO products will reduce the need for farmers to resort to unapproved varieties to boost their yields.
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The investigation uncovered that the team initially went on an unapproved, high-risk mission, but military officials stressed that it was unconnected from the eventual ambush.
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Last year, the church was fined by the Landmarks Preservation Commission for several unapproved changes to its building, the exterior of which is a designated landmark.
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The regulator described initial coin offerings as "a form of unapproved illegal public financing" that "raises suspicions" of fraud and criminal activity, reports the Financial Times.
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The discovery of 22 unapproved genetically modified (GMO) wheat plants has prompted an investigation by federal and state investigators - the third such discovery in three years.
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Proponents of biotech crops in China argue that commercialising GMO products will reduce the need for farmers to resort to unapproved varieties to boost their yields.
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Xi also said that he was open to approving the previously unapproved Qualcomm-NXP deal should it again be presented to him, the White House added.
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Leukemia patient Lu Yong, a prominent member of a local 'buyers club', was arrested last year and charged with selling unapproved drugs and credit card fraud.
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Then, a U.S. court overturned the conviction of drugs salesman Alfred Caronia, who was caught talking to physicians about unapproved uses for the narcolepsy drug Xyrem.
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But their Friday explanation was that he died inadvertently during a physical altercation during an unapproved mission gone awry to bring him back to Saudi Arabia.
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"President Xi also stated that he is open to approving the previously unapproved Qualcomm-NXP deal should it again be presented to him," the readout said.
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At that point, the Saudi government said he was intentionally killed in a physical altercation in an unapproved operation to return to him to Saudi Arabia.
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An additional 17 products (39%) contained one or another unapproved drug, such as growth hormones or steroids, that have been banned by the anti-doping agency.
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The new study, though, found that 91% of the 44 tested products had an unapproved drug -- so just 9% were made of botanicals and not drugs.
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Lyft's own settlement hearing in its case, also brought by lawyer Shannon Liss-Riordon, remains unapproved by a different judge, who rejected it earlier this year.
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He was barred from any unsupervised and unapproved contacts with people under 17, and from any contact with his sister, who was by then an adult.
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The laws purport to provide information regarding the best and worst outcomes of potential treatments — an unfounded claim since outcomes of unapproved therapies are generally unknown.
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They also noted patient access to unapproved drugs might not actually increase if the bill becomes law, since drug companies aren't required to provide the medicines.
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Under the Senate bill, patients with "a life-threatening disease or condition" could obtain unapproved drugs, but eligibility under the House bill was more narrowly defined.
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The Food and Drug Administration generally prohibits pharmaceutical companies from marketing medicines for unapproved uses, as they have not been federally vetted for safety and effectiveness.
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The U.S. FDA determined the product to be an unapproved drug and alerted the MHRA in the UK. (Reporting by James Davey; Editing by Daniel Wallis)
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At Xel-Há, visitors with unapproved sunscreen can swap their brands for samples of safe products and get their own back when they exit the park.
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Another man who alleged he was arrested on an unapproved warrant also sued the Graysville police department in June, according to the Chattanooga Times Free Press.
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This weekend it moved to block apps used to evade the country's internet censors, a decision that fits with Beijing's recent crackdown on unapproved online content.
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Raja Krishnamoorthi, a Democrat from Illinois, said that the agency should "protect the American public from the fraudulent and unapproved medical claims" made by the company.
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In a letter Thursday to CanaRx, the Food and Drug Administration said the company has sent "unapproved" and "misbranded" drugs to U.S. consumers, jeopardizing their safety.
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In recent years, FDA has strengthened its early warning system for likely shortages and its ability to respond to them, including importing unapproved products from abroad.
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" The Moscow Police Department said on its website that "around 500" people had been arrested in the city for taking part in an "unapproved public event.
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The country began rejecting shipments containing millions of metric tons of U.S. corn because they contained the strain, which was unapproved for import, the farmers said.
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BioCorRx generated controversy last month when prison officials in Louisiana said they would offer the company's unapproved naltrexone implant to prisoners who volunteered to take it.
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And while there are a few stores listed on Flipp that we don't fully stand behind (especially since unapproved retailers can sometimes carry counterfeits), most are solid.
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The FCC said the unapproved launch and operation of the company's SpaceBEEs—teeny, tiny experimental satellites—occurred a month after the agency denied its application for deployment.
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It authorizes patients diagnosed with life-ending illnesses to use unapproved medications — so long as they have undergone early testing on humans and are under continual evaluation.
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Six months later, the FDA sent Gomperts a letter, warning her that the agency had determined she introduced "misbranded and unapproved new drugs" into the United States.
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Because of that, the FDA is arguing these products are essentially new, unapproved drugs that have been illegally sold from California to Arizona, according to the complaint.
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In its report, the FAA concluded that NHJ outsourced parts to an unapproved supplier, and a subcontractor fabricated production records and did not follow required manufacturing processes.
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In other words, even after these companies were warned once, they continued selling adulterated products — often with new unapproved substances detected the second or third time around.
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In 2012, a 39-year-old man in Kansas died after taking an unapproved erectile dysfunction drug allegedly labeled as a supplement, the Kansas City Star reported.
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But if they cross the line into health claims — by promising the growth of lashes, for example — then they become "unapproved" drugs and draw the FDA's ire.
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There are approximately, 18 million prescriptions for natural unapproved hormones that are sold by either independent or community-based pharmacies that are sold in a compounded form.
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In 2017, for example, the pharmaceutical company Celgene agreed to a $280 million settlement to resolve allegations that it falsely promoted two cancer drugs for unapproved uses.
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Section 28503(a)(22019) allows use of an unapproved "drug" in an emergency, and the FDCA defines the term "drug" as encompassing both human and animal drugs.
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The case marks the latest effort by the Food and Drug Administration to crack down on the importation of foreign unapproved drugs, known internally as "FUMP" cases.
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Instead, unapproved third-party delivery services had filled that gap by placing large Starbucks orders for delivery to their own customers, often resulting in long store queues.
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While the FDA doesn't allow drug companies to promote these medicines for other conditions, doctors are free to prescribe the drugs for off-label, or unapproved, uses.
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Last year, unapproved Chinese vessels were spotted around waters off the eastern Philippine seaboard, an area known as the Philippine Rise to which Manila holds sovereign rights.
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Jailbreaking your iPhone or rooting your Android has a number of appealing benefits, like allowing you to customize your phone, improve battery life, or download unapproved apps.
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An unapproved antidepressant you've probably never heard of is poisoning people who may be taking the drug for its opioid-like effects, according to U.S. health authorities.
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China bought about 60 percent of U.S. soy exports, worth about $12 billion, before the ongoing U.S.-China trade war and could reject shipments of unapproved varieties.
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Few, in any, states have created the infrastructure to help doctors, who are required to make the request on behalf of their patients, obtain the unapproved medicines.
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Taking drugs for unapproved usages is risky, but Trump has promoted part of that treatment — hydroxychloroquine taken with azithromycin — repeatedly and against the advice of his experts.
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Representative Joe L. Barton, Republican of Texas, explaining why he supported the bill, said he had helped his brother obtain an unapproved experimental drug for liver cancer.
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So some filmmakers began to risk releasing their movies without the code seal of approval, especially as time wore on and the appetite for "unapproved" films grew.
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Over the last decade, Pfizer and Johnson & Johnson have each paid fines of more than $2 billion to settle government charges of illegally marketing unapproved drug uses.
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He has not yet moved to issue final guidelines, first proposed under the Obama administration, that will let drugmakers discuss unapproved uses with entities like insurance companies.
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Agency lawyers listed 24 counts under which Richardson-Merrell violated the law, including that the company had marketed an unapproved drug and claimed that it was safe.
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Agency lawyers listed 24 counts under which Richardson-Merrell violated the law, including that the company had marketed an unapproved drug and claimed that it was safe.
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The F.D.A. said it appreciated the flurry of innovation, though it said it would continue to evaluate unapproved devices to ensure they meet safety and performance standards.
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Mr. Pillsbury said that until this incident, he had never had a visa request denied or go unapproved since he began visiting China in the late 1970s.
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The Food and Drug Administration said Monday it has sent warning letters to televangelist Jim Bakker and six companies for selling unapproved coronavirus drugs and treatment products.
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While the FDA didn't single out piracetam, it's one of the more common and worrisome ingredients in unapproved cognitive enhancement supplements, researchers note in JAMA Internal Medicine.
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What's more, military personnel, like other Americans, can use the FDA's expanded access program, which annually provides access to unapproved drugs and devices to hundreds of people.
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They also say that the bill doesn't mean patients will have access to unapproved drugs because companies will not be compelled to provide them with the medicine.
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" The warning letter calls for CanaRx to "promptly cease causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers and correct all other violations.
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Second, pharmaceutical manufacturers, which cannot profit from the sale of unapproved drugs, have little incentive to provide them to patients and many reasons not to do so.
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It's a big risk for companies, especially in emergencies where health officials may ask for thousands of doses of a still-unapproved experimental treatment that shows promise.
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And with the easy IT management Chrome OS's education license offers, it should be easy to keep students away from unapproved games and focuses on their work too.
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The FDA argued that e-cigarettes — which hit the market here around 20143 — were unapproved drug delivery devices, since they were being touted as potential smoking-cessation aids.
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In cases of rare diseases, patients fighting for their lives are often forced to fight the federal government for access to unapproved therapies by way of clinical trials.
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The verdict came after legal setbacks in recent years for regulators' attempting to curb the promotion of drugs and devices for unapproved uses, known as off-label marketing.
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The FDA operates several International Mail Facilities around the country, monitoring incoming packages for illegal, unapproved, and counterfeit drugs, and found Big Penis at one of the facilities.
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An embryonic stem cellImage: David Silverman (Getty Images)Public health experts have been warning us about clinics offering unapproved and untested stem cell treatments for some time now.
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The FDA and FTC are trying to crack down on companies selling unapproved "natural" alternatives to addiction that can be caused by opioid drugs, like hydrocodone, seen above.
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The hutong revamp is overseen by Beijing's new mayor, Cai Qi, who said city authorities should "dare to play hardball" when taking down unapproved projects and unsafe construction.
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A Monsanto spokesman had earlier said that it was a matter of "grave concern" that some seed companies were attempting to incorporate unauthorised, unapproved technologies into their seeds.
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"People say you're attacking Islam," says Bassam al-Omoush, a former Jordanian minister who teaches at Jordan University's Sharia College and insists on delivering his own, unapproved, sermons.
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In addition, the FDA said it has also issued warning letters to operators of 53 websites that illegally sell unapproved and misbranded prescription drug products to U.S. consumers.
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Preliminary findings from these screening showed U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other conditions.
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A primary concern is that users of the unapproved drug who also take nitrates for diabetes, hypertension, high cholesterol or heart disease could suffer a fatal cardiovascular collapse.
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But it said it now believed it had been using unapproved methods since 1991 — a period that covers dozens of vehicle introductions and millions of cars and trucks.
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In the latest revelations, Mitsubishi says it cheated Japanese regulators and car buyers by using an unapproved method to measure the effect of deceleration during fuel-economy testing.
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The benefits, the indictment said, were used by ineligible beneficiaries and for unapproved purchases, among them a tractor, a pickup truck and almost $17,000 worth of paper products.
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The government has been pressing retail currency operators to narrow what it says is a damaging gulf between the naira's official rate and the unapproved open retail market.
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DOE's Office of Inspector General found that Los Alamos, operated by a private contractor, temporarily used different, unapproved methods to track beryllium and protect workers, contrary to regulations.
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South Korea is not banning imports of feed wheat from Argentina, only the shipment containing the unapproved strain, a ministry official, who declined to be identified, told Reuters.
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Jerry Brown (D) of California vetoed a right-to-try bill last October, disappointing many who had hoped for less-regulated access to unapproved therapies for the dying.
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China bought about 33 percent of U.S. soy exports, worth about $23 billion, prior to the ongoing U.S.-China trade war and could reject shipments of unapproved varieties.
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CHICAGO (Reuters) - The U.S. Department of Agriculture has confirmed the discovery of unapproved, genetically modified (GM) wheat plants growing in an un-planted agricultural field in Washington state.
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Although in a crisis the FDA can use something called emergency use authorization to allow unapproved medical tests, the agency waited until February 29 before actually doing so.
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The FDA's program for expanded access, better known as "compassionate use," allows patients to petition a pharmaceutical company for access to unapproved drugs outside of a clinical trial.
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HHS' Office of the Assistant Secretary for Health, which oversees the women's health office, was led by Don Wright when the emails about unapproved condom images were sent.
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And it includes real-time adverse event reporting and a standard to notify the FDA when a company provides an unapproved drug to a "Right to Try" patient.
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The presence of prescription medicines, often at unknown concentrations, means these supplements are essentially "unapproved drugs" that could be harmful to users' health, according to the study authors.
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In 2007, Kavanaugh was among an 8-2 majority when the D.C. Circuit Court upheld a ruling that terminally ill patients had no constitutional right to access unapproved drugs.
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Read: What you need to know about tianeptine, the unapproved anti-depressant that's poisoning some people New Haven police have reportedly arrested three people in connection with the overdoses.
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West was chasing a lead that Dr. Anindya Sen and his wife, the clinic's office manager Patricia Posey Sen, purchased an unapproved Turkish version of the cancer drug Avastin.
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The scale of stem cell clinics is certainly far larger in the U.S. In a 2019 study, Turner found there were nearly 800 clinics selling unapproved stem cell treatments.
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Rivers sued the clinic in January 2015, alleging that doctors performed unapproved procedures on her mother and waited more than 10 minutes to call 911 when Joan stopped breathing.
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The approval comes days after the White House said China was open to clearing chipmaker Qualcomm Inc's previously unapproved deal for NXP Semiconductors NV "should it again be presented".
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"The government is asking us to carry a sword to fight the enemy with AK-56 rifles," said Ghanwat, who has urged farmers to sow the unapproved GM seed.
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SkySafe's radio frequency signals are projected from a perimeter of nodes or even a Jeep, and force unapproved drones to leave or land while allowing permitted drones to fly.
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But in 2012, a US District Court permanently ordered the agency to prohibit entry of (or release shipments of) foreign manufactured thiopental that is misbranded or unapproved, explained Meyer.
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Last week, the agency once again issued a warning to Genetech over the unapproved use and marketing of these products, as well as its lack of good safety practices.
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The measure would allow the Pentagon to sign off on unapproved medical devices and drugs to be used on military personnel for emergency use, which Politico first reported Monday.
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At issue is a provision in the Senate's National Defense Authorization Act that would let the Pentagon sign off on unapproved medical products for emergency use on the battlefield.
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A federal judge in Montana recently handed down a sentence to Canada Drugs, an online pharmacy that has been selling fake medicines, counterfeit, misbranded and unapproved, to unsuspecting Americans.
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The measure would allow the Pentagon to sign off on unapproved medical devices and drugs to be used on military personnel for emergency use, which Politico first reported Monday.
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SEOUL, July 26 (Reuters) - South Korea rejected a shipment of Argentinian feed wheat after finding unapproved genetically modified strains in the cargo, the country's agriculture ministry said on Tuesday.
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Friedlaender seems like the perfect advocate for Right To Try laws, which allow terminally ill patients to use unapproved drugs that have only passed the FDA's basic safety test.
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In a section labeled "GSK Falsified Its Books and Records to Conceal Its Illegal Marketing Practices in China," the email explained how Glaxo was pitching drugs for unapproved uses.
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They argue that the agency already has a program to help patients get access to unapproved drugs, where physicians can request to let their patient try an experimental medication.
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Mr. Aikawa, Mitsubishi's president, said the company had used unapproved testing methods on an unspecified number of other lines over the years, and was currently reviewing their mileage ratings.
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The White House said China was "open to approving the previously unapproved" deal for U.S. company Qualcomm Inc to acquire Netherlands-based NXP Semiconductors "should it again be presented".
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SEOUL (Reuters) - South Korea rejected a shipment of Argentine feed wheat after finding unapproved strains of genetically modified organisms (GMO) in the cargo, the agriculture ministry said on Tuesday.
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More North Koreans are engaging in illegal social activities and behavior, including mimicking Seoul-style ways of speaking and wearing unapproved hairstyles and clothes to imitate South Korean celebrities.
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In some cases, the treatments may lead to health complications, like blindness in a few extreme cases, and the FDA warns that such treatments are unapproved and potentially harmful.
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But officials in Sichuan have sought to stifle any unapproved commemorations that could rekindle angry questions about why many new buildings, including schools, collapsed in the 7.9-magnitude quake.
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The social media conversation was dominated by questions and jokes like these: How does a DoD letter, unsigned and unapproved, accidentally get sent to another country's head of government?
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The Senate's version of the National Defense Authorization Act (NDAA) would allow the Pentagon to sign off on unapproved medical devices and drugs for emergency use on military personnel.
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That bill would instead expand the situations for which the FDA has authority to approve the emergency use of unapproved medical treatments and seeks to expedite the approval process.
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A spokesman for Bayer said cultivation of unapproved technologies without following mandatory guidelines would set a bad precedent and would be akin to dismantling the country's robust regulatory process.
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But because the site sells unapproved versions of the drugs outside of REMS, the FDA is going after it — part of a broader crackdown on online illegal drug sales.
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The public health advisory notes that the FDA has already "exercised jurisdiction over kratom as an unapproved drug" and detained hundreds of shipments of kratom at international mail facilities.
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When scandalized officials called for the pamphlet to be censored and burned, Milton published another unapproved pamphlet called the "Areopagitica," one of the greatest defenses of free speech ever written.
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One does not have to read Michel Foucault to recognize that there is a long history of using the discourse of mental illness to discipline unapproved and unconventional social behavior.
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China bought about 60 percent of U.S. soy exports, worth about $12 billion per year, prior to the ongoing U.S.-China trade war and could reject shipments of unapproved varieties.
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Investigators have said that while no traces of alcohol or drugs were found in Walker's blood, he was driving down an unapproved bus route at well over the speed limit.
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The government's flat-footed strategy for researching and testing new drugs and the cripplingly high costs of developing therapies spurred black-market clubs that peddled unapproved drugs by the truckload.
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Asked for comment on Zayner's project, an FDA spokesperson said that in general, if a scientist wants to test an unapproved drug in humans, they must notify the FDA beforehand.
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Republican and Democratic lawmakers in Washington are aware of the problem: they've been appropriately concerned for several years about a large number of companies that sell unapproved stem cell products.
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The Rhino products are one example of many sexual enhancement supplements containing unapproved, hidden ingredients that are the same as or chemically similar to the active ingredients in prescription medication.
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"We will only allow sale of wheat products that are confirmed not to contain unapproved genetically modified wheat," South Korea's Ministry of Food and Drug Safety said in a statement.
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Many of the 200-plus roads that linked rural communities were declared "unapproved" and partially destroyed; travelling on those that were still open meant coping with queues, checkpoints and searches.
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Mitsubishi has said it used unapproved methods to calculate mileage for 25 years, and also used estimates - rather than data from tests - to calculate the fuel economy of its minivehicles.
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But Heard shot back on Thursday, filing a cross-complaint against Hanley and his wife Roberta for allegedly including unapproved nude scenes in the final "Producers cut" of the film.
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The healthcare system is plagued by touts trading appointment tickets outside hospitals and a murky world online of healthcare advertisements offering cheap medicine or access to unapproved or experimental procedures.
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The naira was trading at 307.50 on the interbank market on Tuesday, almost 30 percent weaker than on the unapproved retail market where it was quoted at 435 per dollar.
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While drugmaker Avanir Pharmaceuticals has said that many dementia patients suffer from PBA, regulators are concerned that Medicare may be paying for the drug for unapproved and potentially fraudulent uses.
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In Tuesday's letter, the patient advocacy groups pointed to the FDA's compassionate use program, which lets physicians ask the FDA to let a terminally ill patient access an unapproved drug.
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Out of 29 cities and townships around the country that applied for law enforcement grants, just the state of Oregon remains unapproved for 2017 grants, according to The Associated Press.
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Such producers, using scrap rather than iron ore as their input and frequently accused of manufacturing sub-standard product, are largely unapproved and therefore "illegal" in the eyes of Beijing.
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"Facebook has a responsibility to meet its promise to parents that children are not exposed to unapproved contacts, a promise that it appears that Facebook has not fulfilled," they said.
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Stomach issues, often resulting from unapproved munchies, are the No. 1 condition for both dogs and cats, according to the latest "Cost of Pet Health Care" report from Healthy Paws.
|
|
However, the Food and Drug Administration and its equivalents in other countries have issued repeated advisory notices about Melanotan II, urging consumers to stop using and purchasing this unapproved product.
|
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Stories abound of patients or their relatives going to extremes to pay for care: turning to unapproved treatments, sleeping rough or even donning fancy dress in public to raise funds.
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A study published in October found that nearly 800 dietary supplements sold over the counter from 2007 through 2016 contained unapproved drug ingredients, based on an analysis of FDA data.
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The team lacked air support and a complete intelligence picture of the operating environment because it was only resourced for the advisory mission and not the unapproved higher risk mission.
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Opponents of the legislation note that the FDA already has a compassionate use program, allowing physicians to submit an application for a terminally ill patient to access an unapproved drug.
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Last month's imports showed a big gain over January 5903 partly because trade was interrupted a year ago due to findings of traces of an unapproved genetically-modified corn strain.
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The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.
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The team's findings come fresh off the heels of research showing that the agency only occasionally forces companies to recall products that contain legal but unapproved drug ingredients in unknown quantities.
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|
Apple, for example, routinely upgrades the firmware on iPhones to outwit users' attempts to open up the software to unapproved apps and functions - dubbed jailbreaking - said Bunnie Huang, a hardware entrepreneur.
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Several years ago, criminal investigators at the Food and Drug Administration launched a probe into the business, as part of a broader crack down on the importation of foreign unapproved drugs.
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In addition to those top three categories, the investigation also found unapproved ingredients in 14 supplements marketed for joint pain, muscle pain, osteoporosis, bone cancer, sleep issues, gout, or prostate health.
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In that statement, the company said the matter was of "grave concern" and that seed companies illegally attempted to "incorporate unauthorized and unapproved herbicide-tolerant technologies into their seeds" for profit.
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Authorities accused the unit's Medical Initiatives pharmacy subsidiary in Alabama of causing numerous false claims to be submitted to Medicaid for unapproved new drugs, and for defective or compromised new drugs.
|
|
A study just last year found that the agency had pushed for fewer recalls of tainted supplements containing unapproved drugs during Obama's second term than it did during his first term.
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Over 20 percent of these offending products contained more than one unapproved drug ingredient, and numerous contained a cocktail of clandestine chemicals - in two cases, as many as six unlisted ingredients.
|
|
Farmers have said that has led to an increase in the unapproved use of dicamba as growers planting those seeds can spray the herbicide without worrying about damage to their crops.
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Because the field of regenerative medicine is rapidly evolving, he said, close calls may be frequent between what constitutes an individualized treatment and what constitutes an unapproved, possibly harmful medical product.
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Mitsubishi said it had begun using the unapproved tests in 1991 and had later incorporated data based on such tests into mathematical simulations that are also used to estimate fuel economy.
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In 2008, Cephalon likewise entered a criminal plea and agreed to pay $425 million for promoting an opioid called Actiq and two other drugs "off-label" — that is, for unapproved uses.
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The details: Both the House and Senate have passed the same "right to try" bill, expanding terminally ill patients' access to unapproved medicines, and President Trump seems eager to sign it.
|
|
In order to do this, I had to jump through the official and unofficial hoops that had been put in place to prevent unapproved candidates from making it onto a ballot.
|
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President Donald Trump said he will "slash red tape like nobody has even done it before" in a bid to get unapproved coronavirus treatments to patients faster and identify effective drugs.
|
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Read more: Trump undercuts his top infectious-disease expert on whether an unapproved treatment for the coronavirus is safe, a day after the FDA said it had not yet been approved
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Against that backdrop, a group of death row inmates sued the F.D.A. in 2011 in an attempt to force it to block imports of thiopental as a misbranded and unapproved drug.
|
|
It was the first time that the agency, along with the Federal Trade Commission, had issued warning letters for unapproved products related to the coronavirus, which causes the illness Covid-19.
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On Thursday, that hospital offered to treat the child, either as an inpatient in New York or by shipping the unapproved drug for the experimental treatment to the hospital in London.
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The company paid $280 million in July 2017 to settle federal charges that it marketed Revlimid and another cancer drug for unapproved uses, and that it submitted false claims to Medicare.
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|
In fact, Sharpless of the FDA said that "e-cigarette products are not safe" at the congressional hearing, and added they are also technically illegal, as unapproved medical devices, to sell.
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The allegations mirror claims the drugmaker previously resolved in 2012 as part of a $95 million settlement with the U.S. Justice Department that Boehringer illegally marketed the drugs for unapproved uses.
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The conviction is a victory for regulators who have recently suffered legal setbacks in their attempts to curb the promotion of drugs and devices for unapproved uses, known as off-label marketing.
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That year, Rockville managers dispatched investigators to interview 1,100 doctors suspected of buying foreign unapproved drugs from Medical Device King, a licensed wholesale distributor in Great Neck, New York, internal records show.
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The so-called "right-to-try" debate has been a political flashpoint more recently, with Vice President Mike Pence strongly advocating for laws allowing patients a different pathway for accessing unapproved drugs.
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|
In discussions with Trump, "Xi also stated that he is open to approving the previously unapproved Qualcomm-NXP deal should it again be presented to him," the White House said on Saturday.
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Sherman says it's tough to gauge the prevalence of leech therapy stateside, though he speculates that unapproved use might be anywhere from 10 to 20 times than what's officially recorded in hospitals.
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He continued: One does not have to read Michel Foucault to recognize that there is a long history of using the discourse of mental illness to discipline unapproved and unconventional social behavior.
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In 2011, for example, FDA sent a warning letter to NeuLash's owner, warning that sales claims that its prostaglandin ingredient would grow longer and thicker eyelashes made it an unapproved prescription drug.
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Monsanto said using its unapproved technology in seeds could leave Indian farmers "vulnerable to exploitation by opportunistic companies", because they could lose their crops if found to have knowingly planted such seeds.
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Goldman did not mention the U.S. investigation but its expectation was based mostly on a recent Chinese government directive earlier this year ordering local governments to curb illegal and unapproved aluminum capacities.
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The NFL recently sent a memo to its teams saying they'll be fined $25,0003 for posting unapproved video during games, according to a copy of the notice that was obtained by Mashable.
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Doctors can prescribe drugs and devices for off-label use if it's in the best interest of their patient, but the FDA prohibits companies from promoting unapproved uses without including risk information.
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But like any app aimed at children, Alexa skills needed to offer a purchase approval workflow for those in its kids' category, or it would risk unapproved purchases initiated by younger users.
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"We will only allow sale of wheat products that are confirmed not to contain unapproved genetically modified wheat," South Korea's Ministry of Food and Drug Safety said in a statement on Monday.
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Mitsubishi has admitted to using unapproved methods to calculate mileage for 25 years, while it also used estimates, rather than data from actual tests, to calculate the fuel economy for its minivehicles.
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Simmons' lawsuit against Mathews also alleges that the tracking device was leased from a company called Live View GPS, which allegedly ended its contract with Mathews after learning of the unapproved device.
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Following a requested for further information, Citibank found instances of unapproved lending to senior management and a prolonged and serious error in its reporting of loans to related parties, the statement added.
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Separately, the Senate passed a so-called right-to-try bill designed to allow terminally ill patients access to unapproved medications and to provide immunity for physicians willing to administer the treatments.
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And the Food and Drug Administration shut down the primary function of Ms. Wojcicki's business, calling her D.N.A. spit vial "an unapproved medical device" and imposing stricter rules for consumer genetic testing.
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"The Food and Drug Administration and the Federal Trade Commission sent warning letters to seven companies accusing them of marketing illegal, unapproved drugs and making deceptive or scientifically unsupported claims," Laurie writes.
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The Department of Health and Human Services stripped from a government website HIV/AIDS educational material that featured condoms, calling the images "unapproved," according to official correspondence obtained by Kaiser Health News.
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The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients.
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While under this contract, the hospital has been cited three times for sheriffs using excessive force and unapproved tactics on patients over the past five years, with two incidents in 2018 alone.
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China: The government said it would reduce the penalties for the sale and import of unapproved drugs, effectively giving poor and critically ill patients access to cheaper generic versions from other countries.
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China: The government said it would reduce the penalties for the sale and import of unapproved drugs, effectively giving poor and critically ill patients access to cheaper generic versions from other countries.
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That Facebook and other platforms were allowing kids to make unapproved purchases was public information for many years, but just how intentional Facebook was about encouraging this spending was unclear until now.
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Pfizer said it will disclose in its promotional material that narcotic painkillers can carry serious risk of addiction and promised to not promote opiates for unapproved uses such as long-term back pain.
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The traders said Chinese importers had not yet been spooked by concerns following last week's announcement of the discovery of an unapproved strain of genetically modified wheat growing in Alberta, Canada last summer.
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Federal prosecutors say he cashed checks from the company&aposs business accounts between 2007 and 2015 and spent the money on restaurant meals, golf outings, gambling, lottery tickets and other unapproved personal expenses.
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The league office sent out a memo to all 32 teams this week, according to a Mashable report, telling them they'll get fined if they send out any unapproved video during a game.
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Christian Siriano is firing back at a retailer that says he pulled the plug early on a licensing deal they had with him, calling a batch of their clothes low quality and unapproved.
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However, the laws do not operate as advertised: They do not provide access to unapproved drugs but merely the option of asking for such drugs from manufacturers, which are fully free to refuse.
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The federal bills were crafted to strengthen state laws, and, of special importance to proponents, to prevent the FDA from penalizing companies if bad outcomes result from the use of an unapproved drug.
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Although defaults of WMPs issued by smaller banks, non-bank financial institutions and online lenders are not uncommon in China, such incidents at big banks – and this case an unapproved WMP – are rare.
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After being mixed with stem cells, the unapproved concoction was injected directly into the tumors of cancer patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the FDA said.
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Perception of the field has also been hurt by unscrupulous actors selling unapproved, possibly unsterile cell therapies for everything from cancer to lung disease and ALS, prompting a U.S. crackdown this past summer.
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The opposition: Many House Democrats didn't vote for the bill in their chamber, arguing it endangers patients by taking FDA out of the process for allowing a patient to receive an unapproved drug.
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The CAAC also said that the airline would have to submit identification details of all crew operating all services using mainland China airspace, and that flights with unapproved crew lists would be barred.
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It claims that the company took part in a bribery scheme to induce healthcare providers to write more prescriptions and to promote and market Acthar Gel for FDA-unapproved, or "off-label," uses.
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The agency had announced four days earlier that it would permit unapproved tests for 22009 days while developers are preparing their emergency authorization request, but it did not "undo" any regulations or laws.
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Urging consumers not to believe the "hype," the update said, "Some unscrupulous providers offer stem cell products that are both unapproved and unproven," and added that some of those products may be harmful.
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But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.
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In October, the agency issued a public advisory cautioning that SARMs were unapproved drugs linked to "serious safety concerns," including the potential for an increased risk of liver toxicity, heart attacks and strokes.
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Here are some of the key differences: QUALCOMM-NXP The White House said Xi said he was open to approving the previously unapproved Qualcomm-NXP deal should it again be presented to him.
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Some doctors have even charged patients hundreds of dollars to be administered unapproved tests; last week, rapper Cardi B called out fellow celebrities for paying thousands to get tested despite not showing symptoms.
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Among the products it removed were listings for a surgical face mask and a spray disinfectant, though the sellers were able to get their listings reinstated after they removed the unapproved medical claims.
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Studying potential drug therapies in minors is inherently difficult because parents might not want their children to participate in clinical trials, and researchers may be wary of studying an unapproved product in children.
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The Food and Drug Administration on Thursday said a major Canadian drug distributor was selling unapproved and mislabeled medicines to unsuspecting Americans looking to save money on prescriptions, and warned it to stop.
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U.S. federal and state agriculture officials have confirmed an inquiry is under way to figure out how the 22 unapproved GMO wheat plants came to be growing in an unplanted Washington state farm field.
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The unusual trade route has been a challenge even for experienced U.S. merchants and Brazilian buyers, who must ensure grain has all regulatory clearances and does not contain unapproved biotech varieties, grain traders said.
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More than 150 of the products cited in these warnings (about 20%) contained more than one unapproved ingredient, and 28 of them were cited in two or three warnings more than six months apart.
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And so to avoid receiving an "occurrence," as the company calls unapproved absences, contractors who have exhausted their break time come to work sick — and occasionally vomit in trash cans on the production floor.
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Aside from tackling unethical ads such as unapproved pharmaceuticals — an issue that massively impacted Baidu in China — payday loans and counterfeit goods, and deceptive products, Google said it focused its efforts on clickbait advertising.
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The Minsheng case has come at a time when the CBRC has launched a crackdown on banks' transgressions, including bank employees' colluding with clients to forge unapproved lending programmes and sell them to investors.
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Syngenta is potentially on the hook for a big legal bill after U.S. farmers and agricultural firms claimed it sold them seeds for a strain of corn unapproved for export to the People's Republic.
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"If we discover (clients using unapproved VPNs), we will shut down services," said a member of staff at Beijing Sinnet Technology Co Ltd, which operates Amazon's cloud business, Amazon Web Services (AWS), in China.
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Mitchell orders the waterboarding to continue (along with an unapproved technique called "rectal rehydration"), and KSM coughs up details of a nonexistent plot to blow up gas stations and start forest fires in Montana.
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Two former executives of Johnson & Johnson subsidiary Acclarent Inc convicted of distributing a medical device for unapproved uses are seeking to quash subpoenas issued by a former employee suing the company for whistleblower retaliation.
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Bob Filippone, Merck & Co. Filippone, once the top lobbyist for the drugmaker's largest industry group, is working to ensure that a bill allowing terminally ill patients to try unapproved drugs doesn't have unintended consequences.
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A final internal review concluded that he had been given proper care, but had also ignored doctor's orders, often refusing to take blood pressure pills or taking unapproved medicines and alcohol brought by visitors.
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The Pentagon is trying to determine whether American forces involved in a deadly ambush in Niger this month diverted from their routine patrol to embark on an unapproved mission, military officials said on Friday.
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The bill is meant to address a controversial provision of the annual defense policy bill passed by the House on Tuesday that would allow the Pentagon to sign off on unapproved devices and drugs.
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They say the drug approval process is lengthy, and that an FDA compassionate-use program, which allows physicians to submit an application for a terminally ill patient to access an unapproved drug, is cumbersome.
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San Diego-based CareFusion admitted to buying and selling unapproved devices as part of the civil settlement announced by Manhattan U.S. Attorney Geoffrey Berman, which resolves claims first raised against it in a whistleblower lawsuit.
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" In addition, Chinese state media did not mention the White House's claim that "Xi also stated that he is open to approving the previously unapproved Qualcomm-NXP deal should it again be presented to him.
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"It's a matter of grave concern that some seed companies, while suppressing their real intent of profiteering, are attempting to illegally incorporate unauthorized and unapproved herbicide-tolerant technologies into their seeds," a Monsanto spokesman said.
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The deal, approved by a federal judge in Santa Ana, California on Thursday, resolves claims that units of Sincerus Pharmaceuticals Inc engaged in false advertising and unfair competition by mass-manufacturing and marketing unapproved drugs.
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The two separate incidents are the latest to shake public trust in China's healthcare system, the image of which has been hit in recent years by cases involving bribes and the use of unapproved treatments.
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Additionally, "a researcher performed an unapproved emergency surgery on a guinea pig," and a hamster that had escaped from its cage and was found dead in a drain, according to a 2014 report from MLive.
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Weibo Corp, the operator of China's top microblogging site, said this week it would block unapproved video content and work more closely with state media to promote "mainstream" ideas, following a sharp rebuke from regulators.
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The National Organization for Rare Disorders, Parent Project Muscular Dystrophy, and more have rallied together to urge the FDA to improve their expanded access program, as the best means to help patients access unapproved therapies.
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"No less secure than normal cards, by allowing the data element to be reused it is more open to be attained by the cybercriminal then re-used by them as the unapproved user," Aminzade says.
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Prosecutors have charged the founder of Insys Therapeutics and several of the company's sales representatives and executives for their roles in an alleged conspiracy to bribe doctors to use its fentanyl spray for unapproved uses.
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Commissioner Dave Jones said Applied Underwriters Inc and California Insurance Co agreed to submit to a cease and desist order preventing them from selling or renewing unapproved "EquityComp" policies in the most populous U.S. state.
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The article reported that the F.D.A. had serious concerns about how StemImmune obtained hundreds of doses of small pox vaccine containing live Vaccinia virus for use in an unapproved and potentially dangerous stem cell treatment.
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JAKARTA (Reuters) - Indonesian lawmakers on Monday urged authorities to seize from hospitals and health clinics all vaccines made by unapproved manufacturers, after police exposed a syndicate selling fake child vaccines for more than a decade.
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Sotomayor sided with Major League Baseball players during their 1994-95 strike while serving as a federal district court judge, preventing management from replacing the striking players and implementing an unapproved new collective bargaining agreement.
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Ginger Whitehead, the product manager for protective equipment at PEO Soldier, said he has seen "horrific injuries" as a result of a soldier&aposs poor decision to wear unapproved eyewear, with roadside bombs in particular.
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The USDA's Animal and Plant Health Inspection Service has launched an investigation into how an unapproved GMO wheat variety developed by Monsanto Co but never approved by federal regulators came to be growing in Washington.
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To the Editor: Re "After Stem Cell Shots in Their Eyes, 3 Patients in Florida Lose Vision" (news article, March 16): An unapproved medical treatment disguised as research illuminates the dangers of removing consumer protections.
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Back in January 2013, the Atlanta Police Department started investigating inmates "temporarily escaping" from the medium-security US Penitentiary in the city, according to court documents filed in what appears to be the latest unapproved furlough.
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He drinks ("the aftereffects are terrible"), "borrows" medication from friends and family, and has tried Kratom, an unapproved botanical drug that upsets his stomach and this month garnered a health warning from FDA commissioner Scott Gottlieb.
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More than two years after the Food and Drug Administration updated its regulatory framework for regenerative medicine, hundreds of businesses continue to sell unapproved stem cell products and other drugs derived from human blood and tissue.
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The Food and Drug Administration requires that researchers get permission before using an unapproved drug or agent on people in the United States, according to Hank Greely, an expert in biomedical ethics at Stanford Law School.
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"Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective," Gottlieb wrote.
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The FDA already has the power to allow the use of unapproved drugs in emergency situations, as it did with experimental Ebola treatments in 2014, and the Pentagon can already have a say in that process.
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The decision now clears the way for widespread planting next season and removes a hurdle for North American farmers and grain traders, who have to keep close track of unapproved biotech traits that can disrupt trade.
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There are more ways to watch the Olympics (and what happens around the games) than ever before, and yet the IOC is ready to crack down on GIFs, Vines, and other unapproved usage of Olympics footage.
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SEOUL (Reuters) - South Korea has suspended the sale of wheat and flour from Canada after the North American nation announced last week the discovery in mid-2017 of an unapproved genetically modified trait in Alberta province.
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Patients for Affordable Drug Action has spent $85033 million in ads attacking Hugin over his ties to Celgene, which paid a $280 million settlement last summer over allegations that it branded cancer drugs for unapproved uses.
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They argue it will put patients in danger and will give many a false hope about chances of a successful treatment, since drugmakers aren't actually required to give unapproved medicines to patients who ask for them.
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Corden then explained that Swift is not the rapper's only victim of an unapproved recording of a phone conversation, leading into a mock call between the host and West using footage from the now-infamous recording.
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For nearly a decade, the FDA has warned against the use of "Miracle Mineral Solution," an unapproved solution that becomes bleaching agent chlorine dioxide when mixed with a citric acid that consumers are instructed to add.
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The Seattle-based cafe chain blamed a crackdown on unapproved third-party delivery services for much of the slowdown, as well as cannibalization of its own stores with the retailer's rapid expansion in the Chinese market.
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"After testing 72,450 tonnes of feed wheat cargoes imported from Argentina on July 12, an unapproved strain of LMO was detected and we asked to discard or send all back," the ministry said in a statement.
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In 2012, a federal judge dismissed a lawsuit brought by K-V Pharmaceutical Co against the U.S. government seeking to ban sales by pharmacies of cheaper, unapproved versions of its drug Makena to prevent premature birth.
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The "Sicko Mode" rapper isn't the first big star to institute a crackdown on unapproved peddling ... Beyonce and Jay-Z got a similar court order last summer at one of their "On the Run II" shows.
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Showing disrespect toward North Korean leader Kim Jong Un or former leaders, criticizing the government, having an unauthorized interaction with residents, taking unapproved photographs and shopping at certain stores have all been considered crimes, the department said.
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But Brinkley argued that Mill had been given too many chances, sentencing him in November to serve two to four years in prison as a result of his probation violations, unapproved travel, and a failed drug test.
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BEIJING (Reuters) - China's tough supervision of unapproved genetically modified (GM) crops will allow for commercialization of such foods in the future, said an agriculture ministry official this week, defending a recent crackdown on illegally grown GM corn.
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But the supplement industry is only loosely regulated by the Food and Drug Administration (FDA), and a new study is shedding light on just how many of these products contain unapproved and potentially dangerous prescription-strength drugs.
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"Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care," he said.
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Iran's government operates a complex system of web filters to block unapproved sites, but by partnering with a circumvention called Psiphon, ASL219 was able to beat that system, giving citizens a way to tunnel through web filters.
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Losing myself in the sonic fantasy landscapes and angelic harmonies of albums like Queen II or Sheer Heart Attack or Night at the Opera in parentally unapproved, post-bedtime, big-headphone listening: this was my happy place.
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"The court order requires the FDA to refuse admission to the US any shipment of foreign manufactured sodium thiopental being offered for importation that appears to be an unapproved new drug or a misbranded drug," said Meyer.
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Residents and businesses are given from five to 15 days to rectify unapproved construction before "the authorities enforce mandatory demolition with no obligation to compensate any losses", according to notices posted on the walls of many hutongs.
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For example, the US-North Korea standoff is certainly at its lowest tension point in years, ISIS did lose its territorial "caliphate," and the as-yet-unapproved trade deal with Mexico and Canada is better for workers.
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The FDA announced today that U.S. marshals raided StemImmune, a San Diego-based clinic offering a smallpox vaccine to cancer patients, on Friday as part of an crackdown on stem-cell clinics offering unapproved and unproven treatments.
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Subcommittee chairman ties e-cigarette 'epidemic' to unapproved claims made in advertising campaignsJuul confirmed on Wednesday that CEO Kevin Burns had stepped down and that he would be immediately succeeded by K.C. Crosthwaite, an executive at Altria.
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"The FDA will continue to track those selling this dangerous product and take appropriate enforcement actions against those who attempt to evade FDA regulations and market unapproved and potentially dangerous products to the American public," Sharpless said.
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"To me, it seems that the true purpose of this bill is to undermine the regulatory authority of the FDA in regards to unapproved medications," Elizabeth Richardson, a managing associate at Duke's Margolis Center for Health Policy.
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On Wednesday, Mitsubishi Motors said that Tetsuro Aikawa, its president, would resign after the company's disclosure that its engineers deliberately used unapproved test procedures that exaggerated fuel performance by as much as 15 percent on some models.
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Yet the show brushed up against state control for a moment as Major Lazer was barred from welcoming unapproved Cuban musicians — including the rapper Yotuel Romero of the influential Latin rap group Orishas — onstage as surprise guests.
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"You don't want your franchisees running out and buying lettuce and tomatoes from some unapproved vendor," said Justin M. Klein, a franchise lawyer with the firm Marks & Klein who has represented 7-Eleven franchisees in the past.
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On Monday, the FDA and DEA announced that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.
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The ready availability of unapproved treatments at major hospitals around China underlines serious regulatory blind spots in a healthcare system treating 22013 billion people and which is the world's second largest drugs market behind the United States.
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"Last year the FDA, in partnership with international regulatory and law enforcement agencies, acted to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers," Kahn noted.
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His choice to join Eli Lilly's staff was questionable at the time, given that he had previously been an administrator overseeing investigations into the corporation's creation of marketing materials for unapproved use of one of their products.
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BEIJING (Reuters) - Chinese officials have issued warnings to seed dealers and farmers not to use unapproved genetically modified seeds in the country's main crop belt, shortly after Greenpeace said it had found widespread GM contamination in corn.
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"Having this disclaimer in each invoice demonstrates that CanaRx has designed its business to operate in a manner that substitutes the F.D.A.-approved drugs prescribed by the U.S. health care provider with unapproved drugs," the F.D.A. wrote.
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Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.
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In Kentucky, committing "Possession of Anhydrous Ammonia in an Unapproved Container with Intent to Manufacture Methamphetamine" a second time puts you in a "violent" category under the law—and you'll face 20 to 20183 years in prison.
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Her 2013 lawsuit alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.
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DSI was owed 1.16 billion dirhams from "unapproved change orders" relating to three contracts, as well as a further 564 million dirhams due from customers on contracts under discussion and negotiation, according to its third-quarter financial statement.
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While some forms of mixed low-level waste are permitted at Nevada National Security Site, Sisolak says information provided by the Energy Department indicates the unapproved waste shipments from Tennessee violate both site's criteria and potentially federal regulations.
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On Wednesday, the agency announced it was seeking permanent injunctions against two of the most prominent clinics in the US. The injunctions, if successful, would bar the clinics and specific doctors there from performing unapproved stem cell therapies.
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Johnson & Johnson unit Acclarent Inc says that a former sales representative cannot prove she was fired because she complained to her bosses about the company's promotion of a medical device for unapproved uses, rather than her poor performance.
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They also point out that the legislation doesn't necessarily mean terminally ill patients will be able to try the unapproved drugs, as drug companies might not provide them with the medicine and insurers might not cover the costs.
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Off-label use of gabapentinoids has been controversial, however, because these drugs can be addictive, they haven't been proven effective for many common unapproved uses and there's limited long-term safety data, Johansen writes in JAMA Internal Medicine.
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BEIJING (Reuters) - Weibo Corp, the operator of China's top microblogging site, will block unapproved video content and work more closely with state media to promote "meanstream" ideas, the firm said, following a sharp rebuke from regulators last week.
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Last month, the president of Mitsubishi Motors, Tetsuro Aikawa, said he would resign after the company disclosed that its engineers deliberately used unapproved test procedures that exaggerated fuel performance by as much as 15 percent on some models.
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That summer, Glaxo agreed to pay $22015 billion in fines and pleaded guilty to criminal charges in the United States for marketing antidepressants for unapproved uses, failing to report safety data on a diabetes drug and paying kickbacks.
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But Brinkley argued that Mill had been given too many chances, sentencing him in November 2017 to serve two to four years in prison as a result of his probation violations, unapproved travel, and a failed drug test.
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Media in the People's Republic has never been free, but in the past decade, ever-stricter media censorship combined with innovative and sweeping internet filters have made it far more difficult for mainland Chinese to access unapproved information.
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In 2017, Celgene, without acknowledging wrongdoing, agreed to pay a total of $0003 million to the federal government, 28 states and the District of Columbia to settle claims that it had marketed Thalomid and Revlimid for unapproved uses.
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But companies sometimes refuse, fearing that the results could be used against them by the F.D.A. In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.
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In an email to impacted sellers that was cited by CNBC, Amazon said listings were removed because they were "identified as a face mask or related product that makes unapproved medical marketing claims regarding coronavirus or the flu."
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"These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren't adequately tested or disclosed to patients," the FDA said in a statement.
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In the span of a few days, Hermes found evidence that naturopathy was rife with problems, and practitioners who would knowingly give patients unapproved drugs, suggest expensive treatments for all kinds of ailments, and put profits over patients.
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C.I.A. officials have said that Mr. Levinson, who had a contract with the spy agency's analytical unit, went to Kish on a "rogue" unapproved mission and that they would have tried to stop him had they known about it.
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Image: Johnson Space Center (NASA)As it turns out, if the U.S. Federal Communications Commission asks you not to do something, you should probably not do that thing—particularly when it comes to launching to unapproved satellites into orbit.
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That is also what explains the hypocrisy of Senator Ron Johnson (R-WI) who sponsors the federal right to try legislation, which wants to increase access to unapproved drugs, but opposes Medicaid expansion, which increased access to approved ones.
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CAIRO (Reuters) - Egyptian activist Ahmed Maher, a symbol of the popular uprising that ousted Hosni Mubarak in 2011, has been released after three years in prison for breaking a law that bans unapproved protests, his lawyer said on Thursday.
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Even if they were, it may not have made much of a difference: His own research shows that following FDA recalls, supplements with unapproved ingredients are often still available for purchase, and consumers remain unaware of their potential dangers.
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But the EBA amendment is proposing to allow European banks to deny this type of direct access, or screen scraping as it is more commonly known, if it provides a back door to an unapproved Application Programming Interface (API).
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The southern state of Andhra Pradesh last year launched an investigation after finding nearly 15 percent of its cotton acreage was planted with an unapproved variety of genetically modified seeds developed by Monsanto, which dominates India's cotton seed market.
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As discussed above, the FDA can authorize the emergency use of an unapproved product in a situation that poses a public-health emergency, such as an emerging disease like a new strain of pandemic influenza or a Zika outbreak.
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BEIJING (Reuters) - A prominent church pastor in southwest China is being held by authorities on suspicion of inciting subversion, Human Rights Watch said on Thursday, amid a campaign by Beijing to clamp down on religion unapproved by the state.
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Acclarent Inc, a California-based medical device manufacturer bought by Johnson & Johnson Inc in 2010, has agreed to pay $18 million to settle claims that it promoted a device for an unapproved use, resulting in false claims to Medicare.
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Shortly after Four Thieves unveiled its $30 DIY epipen, the FDA issued a statement to the media that said "using unapproved prescription drugs for personal use is a potentially dangerous practice," but didn't refer to Four Thieves by name.
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The settlement announced by California's Department of Insurance on Thursday resolves charges that Applied Underwriters Inc and California Insurance Co steered prospective customers to unapproved or unexpectedly costly policies, using "illegal side agreements" that exposed policyholders to greater risks.
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In August, a federal district judge in Manhattan ruled that the F.D.A. could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company's right to free speech.
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" Looking at a sketch of an upside-down question mark on a skateboard, an unapproved proposal for a public sculpture outside the Reichstag in Berlin after reunification in the 1990s, the artist said, "I had forgotten completely about this.
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JUUL still remains unapproved by the FDA, and it wasn't until a federal judge gave the agency a ten-month deadline in July to review the vaping company's application that the FDA was forced to get that process going.
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One controversial provision that remained in the NDAA after negotiations was one that would have let the Pentagon sign off on unapproved medical devices and drugs for emergency use on the battlefield, rather than the Food and Drug Administration.
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"Right to try" laws have passed in nearly 40 states, but supporters of the bill say federal legislation is needed so that drug companies could feel more free to grant access to the unapproved drugs to seriously ill patients.
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Wednesday's bill, the result of a weekend compromise between the Pentagon and the FDA, expands the situations for which the FDA has authority to approve the emergency use of unapproved medical treatments and seeks to expedite the approval process.
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"Cell-based regenerative medicine holds significant medical opportunity, but we've also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients' health at risk," said FDA director Scott Gottlieb in a statement Wednesday.
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Per reports in Android Police and the Verge, unapproved models of wireless fast chargers will only work at 23 watt speed with the Pixel 3 line, despite it supporting the Qi open wireless power transfer standard used by other manufacturers.
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The issue was highlighted in a recent film that went viral in China which echoed the U.S. "Dallas Buyers Club" about a Chinese cancer patient who had helped others getting unapproved cancer drugs at lower prices shipped in from India.
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The circular said consumer finance firms should be banned from using peer-to-peer platforms or third parties to extend loans to unapproved parties and should not put money into cash or campus loans as well as downpayment loans for property.
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MUMBAI (Reuters) - Many Indian farmers are openly sowing an unapproved variety of genetically modified (GM) cotton seeds developed by Monsanto, as the government sits on the sidelines for fear of antagonizing a big voting bloc ahead of an election next year.
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It argues that, despite the company labeling its products as dietary supplements (which are not regulated by the FDA), what they've really done is introduce unapproved new drugs into the marketplace and promote the products as alternatives to recreational drugs.
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If the Trump administration and Republican lawmakers are really interested in expanding patients' "right to try," they would focus first on giving them the "right to try" approved drugs, not unapproved ones that are not likely to work, or worse.
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NEW DELHI, Oct 14 (Reuters) - A leading Indian cotton producing-state has withdrawn an order asking government officials to inspect fields planted with an unapproved variety of genetically modified (GM) cotton developed by Monsanto Co , the world's No. 1 seed maker.
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The whistleblowers, represented by Bonnett Fairbourn Friedman & Balint and the Evans Law Firm, claim that Gilead defrauded the Food and Drug Administration and government insurance programs by obtaining a key ingredient for three of its drugs from an unapproved Chinese manufacturer.
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Prosecutors said that ev3's sales staff from 2005 to 2009 marketed Onyx for other unapproved uses outside of the brain and continued to do so even after FDA officials warned ev3 executives in 2008 about safety concerns they had.
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"Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, is the wrong answer," the Pharmaceutical Research & Manufacturers of America trade group, or PhRMA, writes on its website.
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Allergan sought the records on Thursday as part of a lawsuit in federal court in Santa Ana, California, accusing Prescriber's Choice Inc and Sincerus Florida LLC of engaging in false advertising and unfair competition by mass-manufacturing and marketing unapproved drugs.
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A new analysis of 10 years of FDA records reveals that from 753 to 2016, almost 750 dietary supplements were found to be contaminated with secret doses of totally unregulated drugs, including prescription medicines, banned and unapproved chemicals, and designer steroids.
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Team did not complete key pre-deployment training or rehearsals Despite going on this unapproved high-risk mission, the US soldiers "did not conduct pre-mission rehearsals or battle drills with their partner force" of Nigerien soldiers, according to the summary.
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"After testing 72,450 tonnes of feed wheat cargoes imported from Argentina on July 12, an unapproved strain of LMO (living modified organism) was detected and we asked to discard or send all back," the agriculture ministry said in a statement.
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There's big difference between deciding to halt or forgo active treatment of an approved drug (which is the usual scenario for entering hospice) and trying an unapproved drug, after exhausting other treatment options (as fancifully might occur under Right to Try).
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The catch is that Saudi Arabia's air force still needs maintenance and logistics support from the jets' countries of origin — the U.S. and the U.K. — and that support could be terminated if the aircraft is used in an unapproved manner.
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A spokeswoman for the Food and Drug Administration told The New York Times this week that it is illegal to import unapproved drugs into the United States, but that the agency will allow imports for personal use in some situations.
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"The Right to Try Act won't remove the primary roadblock facing terminally ill patients who want to test unapproved, investigational therapies: access to the drug by its developer," former pharmaceutical executive Michael Becker writes in an op-ed for NPR.
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Now, under the settlement, it is "barred from making any claims regarding the efficacy of its products without possessing competent and reliable scientific evidence, and from manufacturing or selling any misbranded, unapproved, or falsely-advertised medical devices," Mr. Rackauckas's office said.
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Under the bill, a patient is eligible to receive an unapproved drug if he or she has "a life-threatening disease or condition" and has "exhausted approved treatment options and is unable to participate in a clinical trial" of the drug.
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The bill passed Thursday, the result of a weekend compromise between the Pentagon and the FDA, expands the situations for which the FDA has authority to approve the emergency use of unapproved medical treatments and seeks to expedite the approval process.
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U.S.-based researchers have been allowed to participate in talent recruitment programs, and receive money from both the federal government and overseas, but officials believe problems ensue when foreign funding isn't disclosed or unapproved overseas laboratories are allowed to operate.
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In a 53-page letter to acting FDA Commissioner Ned Sharpless, Krishnamoorthi called the testimony during the hearing "extremely concerning" and urged Sharpless to take action "to protect the American public from the fraudulent and unapproved medical claims made by" Juul.
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Yet according to a new study published this week in Cell, there's no need to travel outside of the US for your bogus stem cell therapy—in fact, there's probably a doctor selling unapproved stem cell treatments right down the road.
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A few weeks later, Apple briefly blocked Google and Facebook from using the App Store to distribute test versions of apps — a hotly debated and fairly dramatic punishment for violations of Apple's rules about putting unapproved software on customers' devices.
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"We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products," Acting FDA Commissioner Dr. Ned Sharpless said in a statement about the action.
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In recent years, the FDA and doctors have noticed people using loperamide—along with other drugs—to achieve a high; others have instead used it as a home remedy to stave off withdrawal symptoms, as an unapproved alternative to drugs like methadone.
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Weibo, which has historically complied with government censorship, came out after the new announcement, saying that it was restricting all videos longer than 15 minutes, adding that it would block unapproved videos and would be working more closely to promote "mainstream" ideas.
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NEW DELHI (Reuters) - A top Indian cotton-producing state has ordered an inspection of fields planted with an unapproved variety of genetically modified seeds developed by Monsanto, which is fighting to retain its market in the world's biggest grower of the fiber.
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Except for GM cotton, India has not approved any other transgenic crop on concerns over their safety, and large foreign companies have been increasingly unhappy at what they say is the infringement of their intellectual property by widespread planting of unapproved seeds.
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Financial Page director Andrew Page and Thomas Ward, who the FCA called an unapproved "de facto" co-director, Henderson Carter director Aiden Henderson and Bank House bosses Robert Ward and Tristan Freer face fines of between 52,725 and 416,558 pounds, the FCA said.
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The Chicago Tribune reports that the Illinois Department of Financial and Professional Regulation took the action against Dr. Ming Te Lin after hearing complaints from healthcare providers that children were being administered unapproved oral versions of childhood shots developed by the doctor.
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" Now the Food and Drug Administration has warned the company behind Coco Loko and Legal Lean Syrup—a "relaxation drink" pitched as a legal equivalent to mixing cough syrup with soft drinks and a Jolly Rancher—that it's peddling "unapproved new drugs.
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A handful of Democrats and Republicans tried to add amendments to address rising drug prices, but committee Chairman Greg Walden said the legislation already takes steps to address that issue by cutting the backlog of unapproved generic drug applications at the FDA.
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"We have concerns about whether the FDA is appropriately devoting its resources to prioritize these efforts against unapproved opioids," wrote the lawmakers, including the panel's Republican Chairman Greg Walden and leading Democrat Frank Pallone, in a letter to FDA Commissioner Scott Gottlieb.
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On its website, the agency posted a warning letter that it sent last week to U.S. Stem Cell Clinic of Sunrise, Florida, accusing the clinic of selling unapproved and nonsterile stem cell treatments and injecting them intravenously or directly into patients' spines.
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California Insurance Commissioner Dave Jones had last June halted the Berkshire units' sale of unapproved "EquityComp" policies after finding that one policy subjected Shasta Linen Supply Inc, a Sacramento employer of 63 people, to hundreds of thousands of dollars of extra costs.
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LAGOS, Jan 13 (Reuters) - The Nigerian naira fell close to 500 against the dollar on the unapproved open retail market due to dollar shortages on Friday as retail currency operators set their quotes for dollar purchases at 399 for next week, traders said.
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The move follows a rape case in Melbourne, Australia in which an unapproved Uber driver was able to bypass "selfie security" checks on the app and was using a friend's account on the night he raped a local woman in her 20's.
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Since then, the antidoping agencies of countries including Kenya and Russia have been sanctioned, either because the countries' policies were out of line with global standards or because the agencies made technical mistakes such as sending doping samples to an unapproved lab.
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A federal judge has ruled that two ex-executives of Acclarent Inc, who were convicted of distributing a medical device for unapproved uses, do not need to testify in a former employee's whistleblower retaliation lawsuit against the company now owned by Johnson & Johnson.
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They claimed not to be responsible for medical devices and referred questions to the China Food and Drug Administration, who told me that their agency ensured the quality of medical devices and stated no private hospital is allowed to use unapproved medical devices.
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It called out Novartis's $475,000 cancer cell therapy Kymriah and its still-unapproved gene therapy for spinal muscular atrophy that Novartis contends is cost-effective at $4-$5 million per patient, while independent groups have concluded its value is less than that.
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In 2015, for example, the agency announced that it had impounded shipments of thiopental that Arizona and Texas had sought to import, saying that it was an unapproved drug that could not be imported into the United States under the 2012 court opinions.
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The experimental Ebola medication remdesivir, already in clinical trials in China, will also be provided to US coronavirus patients under compassionate use rules by the FDA, which allow the use of unapproved drugs in serious cases when no other treatment options are available.
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At 4 months, babies still sharing a room were more likely to have unapproved objects in their cribs (blankets, pillows, positioners); and at 4 and 9 months, parents were more likely to take room sharers into bed with them, also an unsafe practice.
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If phone companies brought the same rules from phone networks over to the internet, attaching unapproved hardware to your line (like a Wi-Fi router) or running software that might compete with the phone company's primary business (say, Skype) could be deemed verboten.
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The increased attention may have irked some neighbors, because an anonymous complaint filed with the Department of Buildings led to an inspection: The house was cited for an illegal conversion of the cellar into a living space with unapproved plumbing and inadequate egress.
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He would be stepping into the job as the F.D.A. is confronting several crises, among them, the continuing outbreak of vaping-related lung diseases, the emergence of cannabis as an unapproved treatment for dozens of ailments, and safety problems with imported drugs.
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"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products," said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research.
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CHICAGO (Reuters) - Japan and South Korea have both taken steps to block certain imports of U.S. wheat after unapproved genetically-modified (GMO) plants from Monsanto Co seeds were found growing in Washington state, a spokeswoman for the U.S. Department of Agriculture (USDA) said on Monday.
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The answers they get help provide a more precise diagnosis, shed light on the expected course of a patient's disease, and in a minority of cases, match a patient with a specific treatment that targets an abnormality, including experimental or unapproved therapies in clinical trials.
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Aside from stating the obvious, that no research supports Gray's claims of sound homeopathy, the board's complaint attacks him for selling over-the-counter, unapproved remedies for typhoid, cholera, and malaria—life-threatening conditions that require serious medical attention and can't be self-diagnosed.
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It seems if the FDA's intent is truly to approve safe drugs sooner, then they would be supportive of a Free to Choose Medicine Track that would offer an effective pathway to expedite unapproved therapies and treatments to patients waiting on their death beds.
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After high-stakes talks on Saturday between U.S. President Donald Trump and Chinese President Xi Jinping in Argentina, the White House said in a statement that China was "open to approving the previously unapproved" deal for Qualcomm to acquire NXP "should it again be presented".
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LAS VEGAS – A grand jury&aposs refusal to indict a former Las Vegas police officer for using an unapproved chokehold in the death of an unarmed man last year drew anguished tears Friday from the dead man&aposs mother and complaints from civil rights groups.
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As of March, Amarin Corp Plc could promote its fish-oil pill for unapproved uses after the FDA decided not to appeal a judge's ruling that the company has the right under the First Amendment to make truthful and non-misleading statements about its products.
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NEW DELHI (Reuters) - A top Indian cotton-growing state has told two local companies that seeds they sold to farmers may have contained traces of an unapproved GM strain from Monsanto, according to government notices seen by Reuters that warn of action against the firms.
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It also tightens China's already expansive censorship program by holding companies accountable for any unapproved information that they allow to spread online, according to The Wall Street Journal, which notes that many of the law's other provisions formalize practices that were already in place.
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But given the app's support for group messaging, it's pretty incredible that Facebook engineers failed to robustly enforce an additional layer of checks for friends of friends to avoid unapproved users (who could include adults) from being able to connect and chat with children.
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SEOUL, Aug 5 (Reuters) - South Korea has not detected any genetically modified wheat in tests on imports of wheat and flour from Washington state, after the discovery of unapproved GM wheat in the U.S. state prompted Japan and South Korea to suspend certain U.S. imports.
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HELSINKI (Reuters) - Nordea on Thursday welcomed a ruling that it and three other banks did not act negligently in issuing unapproved credit ratings and the resulting decision by the European Securities and Markets Authority (ESMA) to revoke fines worth 1.98 million euros ($2.24 million).
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Even in death, former School Superintendent Arlene Ackerman was called out for corruption this summer, based on her cancelling the lawful award of a $28503M a security camera contract to direct those funds to an unapproved, no-bid vendor, citing racial preferences as the reason.
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Altogether, 20173 of the 22017 calls recorded from 29 to 22009 involved people who used tianeptine in combination with other substances, most commonly with an unapproved drug called phenibut, an anxiety drug developed in Russia that has developed its own following on social media.
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Altogether, 83 of the 218 calls recorded from 2000 to 2017 involved people who used tianeptine in combination with other substances, most commonly with an unapproved drug called phenibut, an anxiety drug developed in Russia that has developed its own following on social media.
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Uber, we understand, is working closely with selected partners who come on to the platform to ensure that what they bring is the right blend of contextual experience or entertainment, so don't expect the Uber app to be overridden with unapproved messages and services.
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" The agency declined to comment on any potential further action in Gomperts' case, but added, "We remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women's health.
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Democratic senators wrote to Facebook CEO Mark Zuckerberg Tuesday, probing the company on whether it has done enough to protect children's privacy after The Verge reported last month on a flaw in the Messenger Kids app that allowed minors to chat with unapproved adults.
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The company is now using that stockpile for the trials in China and for individual patients like the one in Washington State, whose doctors sought special permission from the Food and Drug Administration for "compassionate use" so that they could give him an unapproved drug.
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Partners say that they&aposve previously had experiences of having to submit their presentations to AWS for approval, being told to remove mentions of Microsoft Azure and terms like "clouds" and "hybrid cloud," and seeing staff walk around with tape to cover up unapproved phrases.
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When retailers sell unapproved versions of drugs outside of the REMS program — which the FDA says Aid Access and Rablon have — "FDA is well within its regulatory authority to take action," said Tim Mackey, a UC San Diego School of Medicine expert on counterfeit drugs.
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Even though the FDA only inspects a small percentage of the supplements sold in the U.S. every year, the agency issued warnings about 776 different products that contained "undeclared, unapproved pharmaceutical ingredients" between 2007 and 2003, according to the study published this week in JAMA Network Open.
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A few redditors on the Pokémon Go subreddit are trading tips on GPS spoofing, which involves running a rootkit to take control of an Android device's operating system, installing various unapproved bits of software, and letting these new programs report a GPS location of your choosing.
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Because the Salk institute receives money from the National Institutes of Health, an agency of the U.S. Department of Health and Human Services, the lab must abide by federal law, which prohibits it from having any unapproved strains of cannabis in its facility without the proper registration.
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Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc of Kansas City, Missouri received letters for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal, the FDA said.
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After 22 months of working closely with Google, AT&T said it was confident "that there is a near-zero possibility" its ads could end up appearing next to inappropriate or unapproved content on YouTube, Fiona Carter, AT&T's chief brand officer, said in an interview.
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Discovery of the loans - unapproved by parliament - to tuna fishing company EMATUM, security firm Proindicus and Mozambique Asset Management (MAM) led the International Monetary Fund and Western donors to halt support to Mozambique, triggering the collapse of its currency and leading to a default on debt.
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This law "amends statutory authority for use of unapproved medical products during a military emergency, to expedite development and review of medical products for military emergency use, and to improve cross-government coordination on development and review of such medical products," according to a White House release.
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" In a recently published case study, co-author Dr. Raphael Leo, an associate professor in the Department of Psychiatry at the University of Buffalo, characterized the unapproved antidepressant as "available in tablet capsule, and powder form and ... accessible from online commercial sources under the rubric of nootropics.
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The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.
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The company discovered some of the gowns were produced in "unapproved locations that did not maintain proper environmental conditions as required by law, were not registered with the U.S. Food and Drug Administration (FDA) and were not qualified by Cardinal Health," the company wrote in a statement.
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He received treatment from Anthony Galea, a Canadian sports medicine specialist who later pleaded guilty to a felony charge of bringing misbranded and unapproved drugs — including human growth hormone, which is banned by most sports organizations as a performance enhancer — into the United States to treat athletes.
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JPMorgan Chase executives noted that if the Securities and Exchange Commission — currently closed except for emergency matters — was not able to give approvals for stock market share offerings, and mergers went unapproved by other government agencies, it could cut fee revenue for its investment banking operations.
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EditorsNote: rewords last graf Kyle Busch, who was forced to start 39th in the 40-car field after being penalized for unapproved alterations to his car prior to the race, came all the way back to win the Federated Auto Parts 400 at Richmond (Va.) Raceway on Saturday night.
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I would know — until mid-2016, I was the Washington reporter at one of Turkey's last independent and secular newspapers, Cumhuriyet Daily, and our habit of reporting unapproved truths led to me, my editor, and 15 other journalists being labeled terrorists and either jailed or hounded into exile.
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The proliferation of unapproved seeds could force the government to grant approval to the new seed technology, as happened in 2002 when New Delhi legalized planting of the Bt Cotton GM strain, said C D Mayee, head of South Asia Biotechnology Centre, a New Delhi-based non-profit organization.
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Just a week after the DRC declared the Ebola outbreak in August, health-care workers were granted approval to use an unlicensed vaccine made by New Jersey-based Merck & Co. on a "compassionate basis," which allows the use of an unapproved drug when no other options are available.
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Now, if there are no changes to the withdrawal agreement, the deal remains unapproved and the risk of a "no-deal" Brexit – the now infamous "cliff-edge" scenario where Britain leaves the EU abruptly on March 29 with no 21-month transition period and reverts to WTO trading rules.
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"Ramasubbu told the Times he replied four times asking for more information and resubmitted a revised app he hoped would pass the bar, receiving a message in triplicate three days before the deadline: "Your app uses public A.P.I.s in an unapproved manner, which does not comply with guideline 2.5.
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However, it's not uncommon for Apple to borrow ideas from the jailbreak community, having taken "inspiration" from a number of unapproved tweaks in years past, to do thing like enhance notifications, implement Wi-Fi sync, add support for widgets and dynamic wallpapers, improve multitasking and app organization, and more.
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Watch more from Tonic: The new South Carolina suit claims Purdue violated an agreement from the 2007 settlement by continuing to misleadingly market OxyContin by overstating its benefits compared to other painkillers, downplaying its addictiveness to doctors who prescribe it, and encouraging doctors to prescribe it for unapproved uses.
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But the most impactful part of the settlement is what happens next: Goop is now barred from making any claims about the efficacy of its products that aren't backed by reliable science, and from selling "misbranded, unapproved, or falsely-advertised medical devices," according to the Orange County District Attorney.
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The F.D.A. reprimanded Celgene multiple times in those early years, telling the company that it had not adequately warned about thalidomide's risks in its announcement about multiple myeloma, and calling a meeting in December 1998 to warn of its "strong concern" that Celgene was marketing Thalomid for unapproved uses.
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The agency will continue to prioritize regulatory actions against those who place people's health at potential significant safety risk because their unapproved products are unsafely manufactured or are being administered in a manner that puts patients at risk — for example, directly into the bloodstream or central nervous system.
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If the story sounds familiar, that's because it's similar to the model set by Ron Woodroof, an AIDS patient in the United States who in the 1980s began smuggling unapproved medicines from Mexico into Texas to treat his symptoms, and then began distributing the drugs to other patients.
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If there are no changes to the withdrawal agreement, the deal remains unapproved and the risk of "no-deal" Brexit increases — this refers to the now infamous "cliff-edge" scenario where Britain leaves the EU abruptly on March 29 with no 21-month transition period and reverts to WTO trading rules.
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U.S. agrochemicals company Monsanto Co told Reuters late last year that local seed companies have attempted to "incorporate unauthorized and unapproved herbicide-tolerant technologies into their seeds" for profit, leading to the proliferation of illegal seeds, according its own internal investigation and that by the southern state of Andhra Pradesh.
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The Food and Drug Administration notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their confiscated shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be unapproved new drugs and misbranded drugs, FDA press officer Lyndsay Meyer said.
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Regulating donations which allow patients to travel overseas for treatments that are unapproved in their own countries is more difficult, according to the FT. "GoFundMe respects the decisions of patients and their loved ones about what they choose to fundraise for," GoFundMe said in a statement, according to the publication.
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They say the decision to try an unapproved drug is personal — and one between a doctor and a patient — and note that right to try requires that a drug has passed the FDA's phase one testing, a small-scale clinical trial, and is still undergoing clinical trials at the agency.
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President Trump has held daily briefings with members of the White House coronavirus task force, which have increasingly become confusing as Trump contradicts his own experts on issues like the use of unapproved drugs to possibly treat COVID-19 and how long Americans will need to maintain stringent social distancing.
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The FDA sent warning letters to televangelist Jim Bakker and six companies at the beginning of the month for selling unapproved coronavirus drugs and treatment products, including teas, essential oils, tinctures and colloidal silver, which has been cited as not safe or effective for treating any disease, the agency said.
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The pharmacy, Canada Drugs, branded itself as a safe alternative for patients in need of drugs that sell for high prices in the U.S. U.S. prosecutors said the company's business model is based on selling illegally imported misbranded and unapproved drugs from all over the world, according to ABC News.
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Headlines Royal Mail served strike notice by postal workers union Deutsche Bank faces ECB scrutiny over unapproved debt deals MPs seek clarity on next Bank of England governor Overview Trade union Communication Workers Union has told Royal Mail that it is to launch a strike ballot of 110,000 postal workers. on.ft.
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In addition to the civil penalties the company must pay, the statement added, "Goop is also barred from making any claims regarding the efficacy of its products without possessing competent and reliable scientific evidence, and from manufacturing or selling any misbranded, unapproved, or falsely-advertised medical devices," the statement continued.
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In what amounts to just a huge bummer for aspiring geniuses across the country, it seems that nootropics—the brain-boosting supplements with a name as made-up as their actual effects—contain various amounts of piracetam, an unapproved drug that purports to improve brain function, despite little evidence to that effect.
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In February the FDA posted 12 warning letters and five online advisory letters to overseas and domestic companies that are illegally selling nearly 60 products — many sold as dietary supplements — that are unapproved new drugs or misbranded drugs that claim to prevent, treat or cure Alzheimer's and other serious diseases and health conditions.
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Knoepfler co-authored a paper, published in the journal Cell Stem Cell in 2016, that found unapproved stem cell interventions being marketed at 570 clinics across the US. "Hot spot" cities where there were clusters of clinics included Beverly Hills, California; New York; San Antonio; Los Angeles; Austin, Texas; Scottsdale, Arizona, and Phoenix.
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Using text mining and content analysis from the websites of companies offering stem cell therapies, Knoepfler and his co-author Leigh Turner identified 351 companies operating in 570 clinics in the US that were selling unapproved stem cell treatments (they provide a full list of the clinics and their websites in the paper).
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In 2011 the Philippine Food and Drug Administration issued a public warning about an "alarming increase in the unapproved use of glutathione administered intravenously," reporting on adverse effects which included skin rashes, thyroid and kidney dysfunction, and even potentially fatal Stevens–Johnson syndrome, in which the skin peels from the body as if burned.
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Big picture: There are close to 600 stem cell clinics (many of them newcomers) advertising treatments unapproved by the FDA to patients in the U.S. "A lot of these studies are just marketing pitches designed to appeal to people with COPD, multiple sclerosis and Parkinson's disease," Leigh Turner, the study's author, told the Washington Post.
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The officer chased Brown through restricted employee hallways and outside the Venetian resort, where video from the officer&aposs body camera and casino security views showed Lopera using a stun gun on Brown seven times, punching him more than 10 times and putting him in what police supervisors called an unapproved chokehold for 73 seconds.
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To Democrats, that new rule smacked of censorship and was reminiscent of similar efforts by Republicans in Congress to impose fines for unapproved use of photography or video devices in the wake of a raucous June protest by Democrats, who were trying to enact new gun-control laws while shooting cellphone video from the floor.
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A new piece of evidence surfaced Wednesday night in the imbroglio over Hillary Clinton's controversial use of a private server and Blackberry during her time as Secretary of State: A friendly message from Colin Powell detailing how he had used his own unapproved devices and private email during his time as head of the State Department years earlier.
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China has been touting greater access to cancer drugs and pushing to lower prices in a bid to soothe a major social issue in the country, where traditionally many patients with serious illness have had to pay out of their pocket for cutting-edge drugs or have had to buy medicines through unapproved grey market channels.
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" Lee is also accusing his ex-manager of inserting himself into his will and trust, setting up a number of unapproved business dealing that have left him open to lawsuits, investing "tens of thousands of dollars in a tie business that was a scam," forging his signature on comics and using his credit cards for "unauthorized purchases.
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Meanwhile, President TrumpDonald John TrumpFacebook releases audit on conservative bias claims Harry Reid: 'Decriminalizing border crossings is not something that should be at the top of the list' Recessions happen when presidents overlook key problems MORE signed into law groundbreaking "right to try" legislation allowing the terminally ill to explore unapproved medical treatments as a last resort.
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Joffe argued that the right-to-try approach to providing access to unapproved drugs early in their development could put patients in harm's way, as patients receiving the drug are often in very fragile health, doctors often lack the information needed to administer the drugs safely, and little may be known about their risks and benefits, he said.
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After locking down Buddhist monasteries in Tibet and tearing down church crosses in eastern China, President Xi Jinping's campaign against unapproved religion and foreign influence has turned to an unlikely adversary: a small group of Jews whose ancestors settled in this now faded imperial city near the banks of the Yellow River more than 19903,000 years ago.
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As part of the deal, Goop is prohibited from "making any claims regarding the efficacy or effects of any of its products without possessing competent and reliable scientific evidence that substantiates the claims" and "manufacturing or selling any misbranded, unapproved, or falsely advertised medical devices," per a statement from the Santa Clara county district attorney's office.
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"While Callender regularly used the Gearbox credit card for anticipated business expenses such as airfare and meals related to business travel, he also abused the privilege of credit card access by charging unapproved, wholly personal expenses, including family vacations, gun club memberships and firearms accessories, and trying to get six-pack abs," Gearbox attorneys alleged in their lawsuit.
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On a near daily basis, regulated industries are now sending in specific requests to the Trump administration for more rollbacks, including recent appeals from 17 automakers to rescind an agreement to increase mileage standards for their fleets, and another from pharmaceutical industry figures to reverse a new rule that tightens scrutiny over the marketing of prescription drugs for unapproved uses.
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But what's strange about this situation in particular is that in the wake of the grumbling, the CMA erased a promotional social media post featuring Beyoncé and the Dixie Chicks' performance — convincing some observers that even though the CMA said it was due to the footage being unapproved, the organization was bending to conservatives and racists upset with the singer's appearance at the awards.
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For a moment, (I'll leave aside the fact that this unauthorized draft report was leaked to the mainstream media by the so-called deep state of President Obama loyalists without Perry's blessing.) What's just as concerning to me is that this unapproved report is being used by elements of the environmental movement to argue that renewables are ready to take over as the primary source of electricity in America.
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Mark Zuckerberg questioned by senators over children's privacy protections in new letter Makena Kelly reports on fallout from last month's revelation of a vulnerability in Messenger Kids: Democratic senators wrote to Facebook CEO Mark Zuckerberg Tuesday, probing the company on whether it has done enough to protect children's privacy after The Verge reported last month on a flaw in the Messenger Kids app that allowed minors to chat with unapproved adults.
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Its app, originally designed back in 2009, now works on a range of devices, including Mac OS X, Windows, Linux, and iOS devices, if they're jailbroken (meaning, a way to hack the device to run unapproved applications.) In November 2015, the company released an open-source version of its iOS application, which was a brief, but welcome respite from the need to jailbreak your device in order to take advantage of its software.
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A Roche spokeswoman said the company learned of the issues from a Swiss wholesaler in December 20133; the FDA contacted the company in January 2012 after learning counterfeit vials were shipped to the U.S. From 2011 to 2015, FDA investigations into foreign unapproved oncology drugs led to criminal charges against suppliers and distributors as well as more than two dozen doctors, nurses, office managers and clinics who bought the drugs and billed them to federal insurance programs.
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Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California; and Revibe Inc of Kansas City, Missouri received letters for illegally selling unapproved kratom-containing drug products with unproven claims, the FDA said here "Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there's no reliable scientific proof to support their use," FDA Commissioner Scott Gottlieb said in a statement.
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It seems no member of this reality TV family is immune from a little controversy at the moment as Kendall and Kylie face down lawsuits thank to some ill-conceived t-shirts featuring unapproved trademarked images, Khloé handles accusations of copycat designs for her brand Good American and Kim can't seem to catch a break, whether it's accusations of blackface, "cocaine" that turned out to be the pattern on a marble countertop or the outcry from putting her daughter North in a dress featuring a faux corset.
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