Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combin...
CDRH announces a 4/13-15 public workshop entitled Towards Good Simulation Practices in Health Technologies that will discuss modeling and simulation p...
FDA establishes a docket to obtain data and information on vaping-related lung injuries to help identify and evaluate additional steps the agency coul...
Sellas Life Sciences Group says that after gaining FDA feedback, it has finalized the design and plan for a Phase 3 study of nelipepimut-S vaccine in ...
FDA grants Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System.
FDA accepts for review an Epizyme supplemental NDA seeking accelerated approval for Tazverik (tazemetostat for certain patients with relapsed or refra...
FDA accepts for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease.
FDA says it expects the coronavirus outbreak will lead to medical product supply chain disruptions as it reaches out to manufacturers to identifying p...