Federal Register notice: FDA announces that it is continuing a meeting program to advance the use of complex adaptive, Bayesian, and other novel clini...
PTC Therapeutics says enrollment in its Phase 2 Huntingdons disease trial has been paused in the U.S. due to an FDA request for additional data.
FDA says the 8/2 Philips Respironics recall of certain BiPAP and CPAP masks is Class 1.
FDA posts frequently asked questions on UDI enforcement policy that changes with devices labeled on or after 9/24/23.
An FDA advisory committee votes 14 to 1 to recommend the market withdrawal of Covis Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once we...
FDA announces that OMB has approved five information collection notices.
Federal Register notice: FDA amends a 9/8 notice that announced a 10/6 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss Veru Inc.s for tu...
FDA announces five new research projects funded by the Biosimilar User Fee Act.
