The FDA is launching a bonus scheme for its scientific staff at CDER and CBER to accelerate their drug reviews. Read more ...

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine. Over the summer, the ...

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. Articles in this topic offer timely ...

FDA Commissioner Marty Makary on Tuesday named Vinay Prasad the next director of the U.S. Food and Drug Administration’s (FDA) Center of Biologics Evaluation and Research (CBER). Dr. Prasad has openly ...

CDER director Richard Padzur has handed in his retirement papers after under a month in his new position at the FDA. Image credit: Joshua Roberts After less than a month in his new role as head of the ...

At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted ...