[ Price : $8.95]
Two medical device stakeholders urge FDA not to lengthen the review time for Q-Sub submission issue requests filed more than 30 da...[ Price : $8.95]
FDA releases an FDA-483 with eight observations from an inspection at South Koreas Celltrion.[ Price : $8.95]
FDA accepts for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25...[ Price : $8.95]
CBER says a Web site is promoting unapproved HIV tests for sale in the U.S.[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one medical product company Les Produits Chimiques B.G.R.[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for Reclassification Petitions for Medical Devices...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiven...[ Price : $8.95]
FDA approves an expanded use for Vertex Pharmaceuticals Orkambi (lumacaftor/ivacaftor) to include use in certain children ages two...