In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

The FDA's new genAI-assisted scientific review technology, named Elsa, was officially adopted by the agency on 2 June.

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

FDA Commissioner Dr Marty Makary tried to allay industry concerns about recent cuts and outlined his agenda for the future.

FDA Commissioner Dr Martin Makary took the stage at BIO 2025 to detail the way he and his team have been challenging “deeply ...

The FDA says it plans to use artificial intelligence to help speed the approval of new drugs and medical devices.

FDA Commissioner Marty Makary and FDA CBER Director published an article in JAMA that listed their “priorities for a new FDA.

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency ... Elsa's rollout comes after over 2,000 of the FDA's 10,000 workers have been sent packing under ...

Whether or not Elsa was responsible for RFK Jr's "Make America Healthy Again" dossier, which cited AI-hallucinated studies, remains to be seen.Still, the sloppified report could be a harrowing glimpse ...