FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Institute.
Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...
FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after ...
Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for...
FDA warns Chinas Deqing Jiarou Daily Chemical Co. about CGMP violations in its production of finished drugs.
FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality System violations.
Rep. Earl Blumenauer asks FDA to explain why it approved human trials for Elon Musks Neuralink medical device before inspecting its facility.
Two CDER Office of Clinical Pharmacology doctors use a podcast to explain a new guidance on considerations for antibody-drug conjugates.
