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

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

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.

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 ...

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

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

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

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

The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of ...

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 ...

The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...