FDA officials plan to present data they claim links the Covid vaccine to 25 deaths in children at a CDC vaccine panel meeting ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative ...

Emergent BioSolutions has received a $56 million contract extension to supply the US government with doses of the ACAM2000 ...

The U.S. Food and Drug Administration has approved Johnson & Johnson's drug delivery system for a type of bladder cancer, ...

The FDA's new 'green list' is meant to prevent unverified and unapproved GLP-1 drug ingredients from entering the country.

FDA arrives at its rejections for a variety of reasons, though typically due to concerns over safety, effectiveness, or a ...

FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move ...

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.

This article is the latest in the Health Affairs Forefront featured topic, “Health Policy at a Crossroads,” produced with the support of the Commonwealth Fund and the Robert Wood Johnson Foundation.