Tag Archives: FDA

The New York Times reports: Facing mounting government pressure and a public backlash over the epidemic of teenage vaping, Juul Labs announced on Tuesday that it would stop selling most of its flavored e-cigarette pods in retail stores and would discontinue its social media promotions. The decision by the San Francisco-based company, which has more than 70 percent of the …

The Washington Post reports: The Food and Drug Administration, alarmed by a huge increase in vaping among minors, is expected to impose severe restrictions on the sale of most e-cigarettes products throughout the United States — actions that will likely have a significant impact on an industry that has grown exponentially in recent years with little government oversight. As soon …

CNBC reports: The Food and Drug Administration is threatening to pull new e-cigarette products from shelves if the companies don’t prove they’re selling the items legally. The FDA sent letters on Friday to 21 e-cigarette manufacturers requesting information to investigate whether they illegally introduced more than 40 new devices and nicotine liquids to the market without receiving agency approval. Business …

Gizmodo reports: In its ongoing crusade against rad teens, the Food and Drug Administration announced Tuesday that it raided the headquarters of Juul Labs, which is under investigation for potentially marketing e-cigarettes to children. The “unannounced on-site inspection,” executed on Friday, resulted in the seizure of “thousands of pages of documents,” according to the FDA. The surprise inspection of Juul …

USA Today reports: According to a notice issued Wednesday by the United States Department of Agriculture Food Safety and Inspection Service, Cargill Meat Solutions is recalling approximately 132,000 pounds of ground beef products made from the chuck portion of the cow. Officials said the ground beef was produced and packaged on June 21, 2018, and affects 12 different Cargill products. …

The Associated Press reports: U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine. The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. The FDA said in a statement Monday that the digitally-enhanced …

The New York Post reports: Snortable chocolate is so dangerous that its health effects must be investigated by the feds, Sen. Charles Schumer is urging. Coco Loko — a raw cacao powder infused with a “special energy blend” — is marketed like a drug and should be closely regulated, Schumer demanded in a letter to the Food and Drug Administration …

This will be a lifesaver for many people: The Food and Drug Administration on Friday announced its approval of Teva’s abbreviated new drug application the first generic of Gilead’s Truvada (emtricitabine and tenofovir disoproxil). The drug is indicated both as a treatment for HIV-1 in combination with other antiretroviral drugs and for pre-exposure prophylaxis to prevent sexually acquired HIV infection …

The Washington Post reports: President Trump is expected to pick Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration, a person familiar with the nomination said Friday. If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being …

Activist Matt Baume takes a look at the FDA’s recently amended ban on blood donations from gay men and what may come once notoriously anti-gay Tom Price takes over the agency. From the clip description: “Back in the 80s, when the ban was created, it was a best-guess effort to keep blood donations safe since there hadn’t been much research …

Yesterday it was reported that Trump is considering Jim O’Neill, one of libertarian loon Peter Thiel’s cronies, to be the head of FDA. Like Thiel, O’Neill has some really bizarre ideas and sits on the board of Thiel’s Seasteading Institute, which hopes to build floating zillioniare utopias where businesses can operate unencumbered by pesky things like banking laws, environmental protections, …

Bloomberg reports: President-elect Donald Trump’s transition team is considering a Silicon Valley investor close to billionaire Peter Thiel to head the Food and Drug Administration, according to people familiar with the matter. Jim O’Neill, the Thiel associate, hasn’t been officially selected, according to the people, who asked to remain anonymous because the decision process is private, and the Trump team …

The New York Times reports: The Food and Drug Administration gave permission Tuesday for large-scale, Phase 3 clinical trials of the drug — a final step before the possible approval of Ecstasy as a prescription drug. If successful, the trials could turn an illicit street substance into a potent treatment for PTSD. Through a spokeswoman, the F.D.A. declined to comment, …

Fusion reports: Our sci-fi future just got a whole lot closer to becoming a reality, after the Food and Drug Administration gave the okay to a field trial that would release genetically modified Zika-killing mosquitoes in the Florida Keys. On Friday, the FDA released a final environmental assessment of the trial, finding that it “will not have significant impacts on …

Via press release from the ever-combative AHF: Advocates from AIDS Healthcare Foundation (AHF) stepped up efforts to ensure that Gilead Sciences, Inc. be held accountable for promoting off-label use of Truvada for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection. AHF also wants Gilead to be compelled to promote and market use of its AIDS treatment in accordance with …

Via press release from Cytodyn: “Essentially, if PRO 140 is FDA approved, the infected person could finally take a break and go on a vacation without having to remember their pills, and the exact times to take them each day. Some have been on their multiple pill regimen day-in and day-out for decades. Upon FDA approval, all they will need …

The Associated Press reports: The nation’s three-decade-old ban on blood donations from gay and bisexual men was formally lifted Monday, but major restrictions will continue to limit who can donate. The Food and Drug Administration said it is replacing the lifetime ban with a new policy barring donations from men who have had sex with a man in the previous …

The AIDS Healthcare Foundation today announced that it has placed full-page anti-PrEP ads in gay newspapers all over the country. The full ad is below. They write: A new advocacy ad by the AIDS Healthcare Foundation (AHF) takes aim at the failure of pre-exposure prophylaxis (PrEP), the use of Gilead Sciences’ AIDS treatment Truvada to prevent HIV transmission in uninfected …

Twitter has ended its participation in blood drives after a gay man was rejected from donating at their San Francisco headquarters. International Business Times reports: “These are the only policies that the FDA has based on a person’s identification and not any type of risky behavior that they’re engaged in,” said Jim Halloran, Twitter’s Associate Manager of Sales Operations and President …

TIME Magazine reports: The first drug to treat a lack of female sexual desire has been approved by federal authorities. The drug flibanserin, which has been coined “female Viagra,” was approved Tuesday by the U.S. Food and Drug Administration (FDA). The drug is intended to treat hypoactive sexual desire disorder (HSDD)—a persistent lack of libido—in premenopausal women. The agency had …