The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

FDA Commissioner Marty Makary’s pledge to reexamine the safety of medication abortion isn’t just pointless — it’s dangerous.

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 ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

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

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

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

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

Food and Drug Administration Commissioner Marty Makary announced that the agency intends to fast-track reviews for certain ...

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