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

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 ...

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

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

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

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

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 ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

The Center for Science in the Public Interest and FMI-The Food Industry Organization today urged the Food and Drug Administration to go in opposite directions on finishing its front-of-pack food ...

‘Drug decision letters’ are being made public — which is good for manufacturers and patients.