Succeeding with Remote Audits

Artificial intelligence will be a major component, FDA said, of the approaches the agency will be deploying to either reduce, refine, or potentially replace animal testing.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.