Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.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Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.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