FDA warns Czechias Respilon Production about CGMP violations in its manufacturing of over-the-counter drugs.
A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic failures in the pathw...
TransCelerate reports on a 2025 tabletop exercise it convened with the CDER Center for Clinical Trial Innovation that focused on streamlined safety da...
New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles va...
FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.
The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone.
An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...
FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra.
