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CBERs Office of Compliance and Biologics Quality sends an untitled letter to Minneapolis Regenerative Medicine over claims made on...[ Price : $8.95]
FDA grants a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Infectious Otitis Externa Drugs for Topical Use in Dogs.[ Price : $8.95]
FDA finds deficiencies in Ascendis Pharmas NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Marketing Submission Recommendations for a Predetermined Ch...[ Price : $8.95]
A JAMA research letter says 54% of accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in ...[ Price : $8.95]
FDA approves an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Mercks Keytruda in certain patients with loc...[ Price : $8.95]
FDA issues a 14-page Form FDA-483 to Global Pharma Healthcare in Tamilnadu, India that cites significant GMP deficiencies with its...