FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs and biologics used ...
FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during clinical trials for...
Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy pacemakers following ...
Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.
FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harb...
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...
Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspections of CDER-regul...
Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of the agency.
