Vinay Prasad leaves FDA apparently due to backlash from the agency's handling of potential deaths related to Sarepta's ...

Vinay Prasad, the U.S. Food and Drug Administration's chief medical and science officer, has left the health regulator, the U ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

FDA Commissioner Marty Makary is spearheading a major overhaul of the agency’s dietary guidelines, including rewriting the 1992 food pyramid.

WASHINGTON — Even before he took over the Food and Drug Administration, Marty Makary called for frequent, transparent meetings of the independent panels that advise the agency on ...

Meanwhile, FDA Commissioner Marty Makary highlighted the speed with which the tool was rolled out. "I set an aggressive timeline to scale AI agency-wide by June 30," Makary said.

The Trump administration‘s “Make America Healthy Again” goals depend on negotiations with food and healthcare industry leaders rather than regulation, the heads of the Food and Drug Administration and ...