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Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices: Current Good Manufacturing Pr...[ Price : $8.95]
FDA warns Dollar Tree about its receipt of over-the-counter drugs manufactured by foreign contract firms that have received FDA Wa...[ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofi...[ Price : $8.95]
CGMP consultant Dave Elder analyzes a draft International Conference on Harmonization guidance on technical and regulatory conside...[ Price : $8.95]
Former CDRH branch chief Morris Waxler tells CBS News LASIK eye surgery should be pulled from the market due to complications.[ Price : $8.95]
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to not recommend approval of Eli Lilly and Boehringer Ingelheims ...[ Price : $8.95]
FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two resear...[ Price : $8.95]
FDA approves BeiGenes Brukinsa capsules to treat some adults with mantle cell lymphoma.