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% ...
RAPS

FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both ...
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 ...