Tag: FDA

The published literature is misleading, as the negative Xanax trials either went unpublished or were spun to appear positive.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

Members of the U.S. Food and Drug Administration’s Psychiatry Products division go on the defensive in a new article, responding to concerns about the agency’s approval of digital aripiprazole.

From MedPage Today: "The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder (MDD). For example, the new guidance...

From The Lown Institute: New investigations and research are beginning to show the dangerous consequences resulting from the FDA's lack of oversight of medical devices. "It sounds crazy...

From STAT: A decade after the Food and Drug Administration Amendments Act went into effect, requiring the results of clinical trials to be reported on the government website ClinicalTrials.gov, the government has never levied a single monetary penalty or withheld research funding under the law.

From The New York Times: TV drug ads have dramatically increased in the past few years. According to Kantar Media, a firm that tracks multimedia advertising,...

From Scientific American: The FDA seems determined to prevent the public from accessing valuable data about the safety, efficacy, and potential adverse effects of the...

Drugs to treat serious or life-threatening conditions can receive accelerated FDA approval, but may expose patients to increased safety risks and reduced efficacy.

From Scientific American: The FDA has announced its approval of Kymriah, the first gene therapy in the U.S. However, gene therapy remains far from fulfilling...

From FDA in Brief: The FDA seeks input from consumers and medical professionals on making sure the drug risk information in statements included in direct-to-consumer...

The Anything But the Company Drug playbook involved digging deep into the medical records of the person reporting a problem in order to find the ingrown toenail at the age of two that was possibly the cause. And of course if something else was possibly the cause, then we can’t conclude that our drug did it.

Jim Gottstein, president and founder of the organisation Law Project for Psychiatric Rights, talks about his own experiences with the psychiatric system, patient rights in mental healthcare and the recent trial between Wendy Dolin and the UK Pharmaceutical manufacturer GlaxoSmithKline.

From Pacific Standard: This past Tuesday, the Senate confirmed Scott Gottlieb as head of the Food and Drug Administration. "Although some Senate Democrats had worried about...