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

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 ...

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 ...

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

On first glance, Dr. Vinay Prasad’s medical credentials sound impressive. But look closer and you’ll find a narcissistic attention-seeker peddling misinformation, whose views will cost lives.

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

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

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 ...

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

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