RAPS

FDA official: CDER warning letters up 50% in FY 2025

WASHINGTON – The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% ...
CNN

Longtime FDA oncology leader named agency’s top drug regulator

The US Food and Drug Administration said Tuesday that Dr. Richard Pazdur has been named head of its largest division, the Center for Drug Evaluation and Research, which oversees the safety and ...
RAPS

Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.