News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next FDA commissioner.
Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter demonstrates the need f...
Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.
FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.
Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potential battery malfunctio...
Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness reasons.
FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.
New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presented in a clear, conspi...
