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 ...

The FDA says it plans to use artificial intelligence to help speed the approval of new drugs and medical devices.

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

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

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

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

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

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

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

In case you haven't had enough artificial intelligence, the US Food and Drug Administration is now outsourcing its oversight duties to a large language model (LLM.) In an article published in the ...

House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee Thursday — but ...