The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana drug manufacturing facility.
FDA approves a Merck BLA for Winrevair (sotatercept-csrk) for injection for treating adults with pulmonary arterial hypertension.
Federal Register proposed rule: FDA proposes to ban electrical stimulation devices intended for self-injurious behavior or aggressive behavior.
Federal Register notice: FDA makes available a guidance entitled Handling and Retention of BA and BE Testing Samples.
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.
