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

CDER official reflects on a decade of patient-focused drug development

Multistakeholder meetings held as part of US Food and Drug Administration (FDA) patient-focused drug development efforts have left a huge impact on everyone involved, according to Theresa Mullin, PhD, ...
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 ...
FiercePharma

FDA official challenges safety, efficacy of Aurinia lupus med in now-deleted LinkedIn post targeting surrogate endpoints

A now-deleted LinkedIn post from a top FDA official has raised the hackles of Aurinia Pharmaceuticals as industry watchers puzzle over the official's decision to target the approvability of surrogate ...

FDA renews crackdown on GLP-1 compounders

The U.S. FDA has sent a new batch of warning letters to telehealth firms that allegedly made false and misleading claims about low-cost compounded versions of GLP-1 drugs, the popular class of ...