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Federal Register notice: FDA makes available a draft revised guidance for industry on generic digoxin tablets.[ Price : $8.95]
Federal Register notice: FDA announces that it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydroc...[ Price : $8.95]
FDA approves Novartis Kymriah as the nations first gene therapy, indicated for treating a form of leukemia in young patients.[ Price : $8.95]
FDA extends by three months a Biocon BLA for a proposed trastuzumab biosimilar product (Roches Herceptin), indicated for HER2-posi...[ Price : $8.95]
FDA releases the FDA-483 with two observations from a 2016 inspection at Wickliffe Pharmaceutical.[ Price : $8.95]
FDA reminds healthcare professionals that using thermoregulation devices during surgery, including forced air thermoregulating sys...[ Price : $8.95]
A CDRH webinar suggests questions to consider when determining whether to qualify a proposed medical device development tool.[ Price : $8.95]
FDA accepts an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival data from the Ph...