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 ...

The FDA is adopting a new regulatory framework that will change the criteria for approval of COVID-19 vaccines.

WEDNESDAY, June 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) says it plans to use artificial ...