FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the use of artificial inte...
FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic im...
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.
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New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles va...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.
