FDA releases an FDA-483 with eight observations from an inspection at South Koreas Celltrion.
FDA accepts for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), an investiga...
CBER says a Web site is promoting unapproved HIV tests for sale in the U.S.
FDA releases its latest batch of Warning Letters that includes one medical product company Les Produits Chimiques B.G.R.
Federal Register notice: FDA submits to OMB an information collection extension for Reclassification Petitions for Medical Devices (OMB Control Number...
Federal Register notice: FDA makes available a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Med...
FDA approves an expanded use for Vertex Pharmaceuticals Orkambi (lumacaftor/ivacaftor) to include use in certain children ages two through five years ...
FDA approves magnetic resonance-conditional labeling for Envoys Esteem middle ear hearing implant.