Federal Register final rule: FDA posts a final rule on direct-to-consumer advertisements and a requirement that the major statement must be presented ...
FDA publishes a draft guidance with questions and answers on translating GLP study reports into English.
Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.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Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.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...
