Two attorneys who represented the Canton, MA-based Judge Rotenberg Center in its court case against FDAs efforts to ban the use of an electroshock or ...
The Biotechnology Innovation Organization suggests ways FDA can improve a draft guidance on potency assurance for cellular and gene therapy products.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.
