FDA Review posts product approval summaries for the week ending 4/8/2022.
Federal Register notice: FDA makes available two medical device guidance documents for the Safety and Performance Based Pathway.
Federal Register notice: FDA makes available a final guidance entitled E8(R1) General Considerations for Clinical Studies.
Federal Register notice: FDA announces a 5/11-12 Pediatric Oncology Subcommittee meeting to discuss FDA decisions on sponsor plans and requests for wa...
Medtronic recalls certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error that could cause the devices to not deliver basal ...
CDERs Office of Prescription Drug Promotion issues Bausch Health Companies an untitled letter that cited the firm over its promotional communications,...
A bill introduced by Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) pressures FDA to issue its final rule within 30 days allowing over-the-co...