While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

Expect the FDA to double-down on evidence-based decisions and clear communication of risks/benefits, as this leadership views public trust as essential for biotech innovations to succeed.

“Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting FDA commissioner and former principal deputy commissioner of food ...

“The FDA as we've known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” Dr. Robert Califf ...

The departure comes just days after the FDA's top vaccine official stepped down over disagreements with health secretary RFK Jr.'s over the safety of vaccinations.

Industry leaders are lauding proposed changes to FDA’s food program outlined in a highly-anticipated external review by the Reagan-Udall Foundation published yesterday that includes calls for a ...

FDA announces overhaul as baby formula shortage continues Longtime problems in structure, function and leadership at the agency have left the American food system vulnerable to outbreaks of food ...