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FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs...[ Price : $8.95]
FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during...[ Price : $8.95]
Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy p...[ Price : $8.95]
Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.[ Price : $8.95]
FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cho...[ Price : $8.95]
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path ...[ Price : $8.95]
Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...[ Price : $8.95]
Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...