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

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty ...

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

According to an internal email, the agency may be in for more consolidation in areas including human resources, ...

Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on ...

US regulators, under the guidance of FDA Commissioner Marty Makary, are launching a program to accelerate drug approvals, ...