An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...

Contamination control strategies define risk analysis, mitigation, and corrective actions to support sterility assurance.

Dublin, April 15, 2026 (GLOBE NEWSWIRE)-- The "Webinar: Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations (May 5, 2026)" webinar has been ...

Draft guidance targets reduction/elimination of nonhuman primate testing for monoclonal antibodies, signaling higher regulatory receptivity to alternative nonclinical packages when scientifically ...

Jason Mast is a general assignment reporter at STAT focused on the science behind new medicines and the systems and people that decide whether that science ever reaches patients. You can reach Jason ...

The Food and Drug Administration (FDA) is taking the first steps toward potentially easing access to certain peptide injections that are currently restricted due to safety concerns. The agency on ...

The Food and Drug Administration is asking Eli Lilly to gather more safety data on its new weight loss pill, Foundayo, including whether it could be linked to liver and heart problems, according to ...

April 13 (Reuters) - The U.S. Food and Drug Administration has approved the expanded use of Travere Therapeutics' (TVTX.O), opens new tab drug to treat a rare kidney disorder, the company ‌said on ...

Amber is the Associate Editorial Director overseeing news content for Health, ensuring that readers stay up-to-date on trending topics like COVID-19, as well as the most recent research in the health ...