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Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.[ Price : $8.95]
FDA warns Cipla about CGMP and other violations at its Madhya Pradesh, India-based drug manufacturing facility.[ Price : $8.95]
SoClean recalls its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and acc...[ Price : $8.95]
Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses o...[ Price : $8.95]
FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.[ Price : $8.95]
FDA delays a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene v...[ Price : $8.95]
Federal Register notice: FDA announces a 12/14 public meeting entitled Advancing the Development of Therapeutics Through Rare Dise...[ Price : $8.95]
Federal Register notice: FDA seeks information to better understand the status of trading partners interoperable systems and proce...