FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE.
Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.
FDA clears a Zeta Surgical 510(k) for its Zeta Navigation System for use with expanded instruments and enhanced hospital connectivity.
FDA raises questions to be considered by members of its General and Plastic Surgery Advisory Committee about IceCare Medicals ProSense cryoblation sys...
FDA warns the Kittanning, PA-based Armstrong County Memorial Hospital IRB about objectionable conditions identified in a Bioresearch Monitoring Progra...
FDA commissioner Robert Califf says collaboration with external stakeholders is needed to adequately monitor and regulate artificial intelligence.
Acadia Pharmaceuticals sells its Rare Pediatric Disease Priority Review Voucher for $150 million.
FDA approves an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant.
