Inside AI Policy

May 16, 2025

FDA chief sets June 30 deadline for AI use in product reviews

May 9, 2025

Food and Drug Administration Commissioner Marty Makary gave all product reviewers less than two months to start using artificial intelligence, days after he touted the ability of data-driven endpoints to dramatically speed drug approvals, Inside Health Policy reported.

FDA said in a May 8 press release that it is working toward full agency-wide implementation of AI-driven reviews by June 30.

“We're not wasting any time,” Makary said May 6 at an American Hospital Association annual meeting. “This can help...


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