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Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.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 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...
A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisements major state...
Bayer stops its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibbs Eliquis) in patients with atrial fibrillati...
