New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...

After the FDA issued a global recall last year of "sartan"-based drugs contaminated with a possible carcinogen, there's been plenty of blame to pass around. The most recent recipient of regulators' ...

Citius Pharmaceuticals Inc. appointed drug industry veteran Kelly Creighton as executive vice president of chemistry, manufacturing and controls, the company announced Nov. 5. Creighton will be ...

The agency outlined the adjustments it's willing to make to "remove barriers and perceived misconceptions" for innovative medicines.