FDA releases a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with...
FDA posts a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway.
FDA approves an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssens Remicade, indicated for treating Crohns disease, ulcerative colitis, ...
FDA steps up its enforcement efforts against violative cell/tissue products, and issues warnings against Liveyon Labs on the heels of similar actions ...
A federal court convicts New York physician Gordon Freedman for participating in a scheme to receive bribes and kickbacks through sham educational pro...
Federal Register notice: FDA announces a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management A...
FDA asks manufacturers of Zantac and Axid to test for NDMA impurities and not release lots that are above the acceptable daily limit.
Federal Register notice: FDA is seeking comments on an information collection revision for Dietary Supplements good manufacturing practices.