FDA warns Frances Laboratoires Clarins about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA issues a final guidance on best practices for using animal studies to evaluate organ preservation devices.
FDA issues a safety alert on certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers about issues that may cause thei...
Federal Register notice: FDA makes available a final guidance entitled Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser ...
Federal Register notice: FDA makes available a final guidance entitled Laser Products Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1(L...
Federal Register notice: FDA makes available a final guidance entitled Medical X-Ray Imaging Devices Conformance with IEC Standards.
The CDER Office of Prescription Drug Promotion proposes a study of accelerated approval disclosure used in direct-to-consumer promotional materials fo...
A Tufts Center for the Study of Drug Development Impact Report says drug developers are making increasing use of artificial intelligence in a variety ...