Former medical device regulatory affairs specialist Peter Stoll pleads guilty on one felony count for distributing medical devices without FDA clearan...
CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.
The Biotechnology Innovation Organization says FDAs new Rare Disease Endpoint Advancement Pilot Program will provide greater clarity on how to develop...
FDA signs off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firms troubled BD Alaris Infusion System.
FDA releases the form FDA-483 with one observation from an inspection at Chinas Wuxi Sta Pharmaceutical contract manufacturing organization.
Abiomed recalls all lots of six models of its Impella heart pump due to a potential risk for impeller blade destruction.
The Vir Biotechnology VIR-2482 investigational influenza A monoclonal antibody vaccine fails to meet the primary and secondary endpoints in a Phase 2 ...
FDA tells the DC federal court there are five reasons why it should dismiss a Norwich suit seeking to force the agency to approve an amended ANDA for ...
