China has defied regulations on such products, which vape stores across the U.S. have commonly sold despite FDA restrictions, Commissioner Marty Makary said.

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

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.

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug review and speed up approval is not here yet.

Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...

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

Dr. Mehmet Oz and Dr. Marty Makary argued that regulations from their respective Centers for Medicare & Medicaid Services and Food and Drug Administration are not as effective as public-private ...

Mary Talley Bowden, MD, founder of Americans for Health Freedom, an advocacy group that has lobbied against mRNA shots, ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...