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 medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as burdensome recommen...
CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk re...
FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclofenac and omeprazole.
FDA assistant commissioner Justin Green reports on over 290 arrests last year by the agencys Office of Criminal Investigations.
Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for reasons of safety or e...
Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency Use Authorization (...
