FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s ...

Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...

The FDA’s accelerated approval pathway plays a vital role, and scrapping it or reversing course on already-approved therapies ...

In case you haven't had enough artificial intelligence, the US Food and Drug Administration is now outsourcing its oversight ...

A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.

In 2023 Dr. Vinay Prasad said that scientists who recognized the limitations of randomized-controlled trials (RCTS) were ...

When two of medicine’s most outspoken reformers publish a roadmap for the FDA, you expect at least coherence. Instead, we get ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...

The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

Last Thursday during a roundtable on stem cell therapies, new FDA Commissioner Marty Makary referred to EBM levels of evidence as an artificial and dogmatic construct. Apparently Dr. David Katz's "mor ...

AI is slowly permeating all corners of the federal government, including the Food and Drug Administration, where, according ...

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s ...