Tag: FDA

Former FDA officials write that claims that the black warning led to an increase in youth are "factually inaccurate in ways that are directly verifiable."

Rejected by the FDA four times; an advisory committee vote against approval. Yet in 2023, gepirone (Exxua) was approved for depression.

“The main take-home message is that regulatory approval doesn't mean a device works. It means it's safe,” according to Katya Rubia, PhD.

Established drugs were repurposed, “me-too” drugs were approved, and even the few new biological approaches lacked clinical utility.

From The Lever. "The pharmaceutical industry spent decades manipulating the country’s top drug regulator into rubber-stamping its products. The Trump administration is making matters...

Adam Urato and Joanna Moncrieff join Robert Whitaker on the Mad in America podcast to discuss the risks posed by maternal use of antidepressants.

From CNN. "To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market,...

An FDA expert roundtable on Selective Serotonin Reuptake Inhibitors (SSRIs) and pregnancy to facilitate discussions on the safety of the developing child. Held on...

From The Lever (free subscription required): "Federal regulators have authorized hundreds of drugs without evidence they work, and many are dangerous. Nieraj Jain was puzzled...

From Antidepressantinfo.org: "We’ve submitted a petition to the FDA calling for stronger warnings and safer tapering guidance for SSRIs and SNRIs. Now we need...

From Med City News. "A Bristol Myers Squibb drug whose landmark FDA approval introduced the first novel mechanism for treating schizophrenia in decades has...

Concerns, from functional unblinding to sexual assault in the clinical trials, led this week to a full repudiation of Lykos' MDMA-assisted therapy.

The published literature is misleading, as the negative Xanax trials either went unpublished or were spun to appear positive.

Response and remission rates were the same in the drug versus placebo groups, and Lexapro increased suicidality sixfold.

Drug regulators frequently approve drugs despite contradictory clinical trial results and without evidence of clinical benefits.

The FDA approved Biogen's failed drug aducanumab, overriding the 10-0 recommendation of its own advisory committee. Three panel members resigned in protest.

The FDA collaborated with Biogen to conduct repeated re-analyses of aducanumab for Alzheimer's and FDA committee members are raising concerns.

More than 200 people signed an open letter to the FDA requesting electroconvulsive therapy’s safety studies and electrical dosing protocols.

The FDA has finally acknowledged the adverse effects of benzodiazepines, the dangers of withdrawal, and that the current packaging does not sufficiently warn of these harms.

The UK’s Medicines & Healthcare Products Regulatory Agency is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.

From Science: "Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining...

From The Washington Post: "When federal regulators started giving certain drugs 'breakthrough' status in 2012, pharmaceutical company interest exploded. The goal was to speed up...

From The Hastings Center Report: "Addyi, a drug that made a splash when it was approved in the summer of 2015 as the first...

From Forbes: "A new Netflix documentary — The Bleeding Edge — highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always,...

From ProPublica: "The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once...