FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.
UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...
FDA issues an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide c...
FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.
