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“The volume of evidence behind a therapy has become inversely correlated with public trust in it,” writes Vikas Patel.

The finding contradicts a familiar mantra from industry and many patient groups that speedy access should be paramount.

In the 13th essay of the Legacies of Eugenics series, Margaret R. Eby shows how, during feminism’s first wave, white women physicians became the unlikely standard-bearers of eugenics.

"Watching my mom die of ALS was one of the most awful things I’ve gone through. I don’t want my children to see me suffer like that."

YouTube video by Saturday Night Live

The FDA approves leucovorin for a rare brain disorder while retreating from top officials’ earlier insistence that it could benefit many children with autism.

The FDA is cutting back on public advisory committee meetings, even as the public and other stakeholders seek more transparency.

Given their obligations to ensure ethical research, we argue that institutional review boards (IRBs) bear a responsibility to minimize the possibility that proposed clinical studies will terminate ea...

Dr. Vinay Prasad will depart in April, after a year leading the division that approves vaccines and biotech drugs.

In a strikingly blunt briefing, a senior FDA official accused uniQure of pushing “distorted” data to mask a “failed” therapy for Huntington’s disease. | In a strikingly blunt briefing, a senior FDA of...

Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for the Trump administration.

YouTube video by PBS NewsHour

This survey study assesses understanding of and responses to the proposed US Food and Drug Administration conditional drug approval pathway among individuals who have received prior treatment for canc...

The Open Notebook and Retraction Watch are thrilled to announce a new fellowship program funded by The Center for Scientific Integrity. This six-month program will equip up to six reporters and editor...

Podcast Episode · Research Ethics Reimagined · February 20 · 50m

If confirmed by the US Senate, Jim O'Neill would be the first non-scientist or engineer to lead the agency, a big funder of US basic research.

This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The p...

This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

Students were seen running away from their bus stop on Thursday morning as ICE agents conducted an operation at an apartment in Lindenwold, NJ.

An informative webinar on the FDA guidance Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

The FDA has rejected a rare disease therapy from Disc Medicine, an early recipient of a commissioner's voucher from the agency.

This Viewpoint discusses the lawfulness and credibility of the US Food and Drug Administration’s recent move to using expert panels rather than advisory committees for decision-making.