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

FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...

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

Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...

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

But current and former agency staff, as well as medical ethics experts, say recent cuts at the FDA are already making it more ...

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

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

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

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Curay, the FDA’s acting top drug regulator, is stepping down from her post after serving at the agency for more than eight ...