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 ...

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 ...

This story is from the next print edition of MIT Technology Review, which explores power—who has it, and who wants it. It’s ...

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

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

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

When two of medicine’s most outspoken reformers publish a roadmap for the FDA, you expect at least coherence. Instead, we get a curious blend of tech evangelism, selective evidence, and lofty ...

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

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

The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA ...

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

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