Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advis...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Biomarin Pharmaceuticals Palynziq (pegvaliase-p...
FDA releases a draft guidance entitled Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with...
FDA posts a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Performance Based Pathway.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...