Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product Development.
Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated for treating Niemann-P...
FDA clears ImmersiveTouchs ImmersiveAR virtual and augmented reality operating room platform.
CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures for INDs received by t...
AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate p...
FDA grants PharmasstX an orphan drug designation for epigallocatechin gallate, a green tea extract for treating inflammatory bowel disease pouchitis.
FDA posts 30 signals of serious risks/new safety information identified by the FAERS in the first quarter of 2024 and is evaluating the need for regul...
FDA approves a Cordis PMA for its Mynx Control Venous Vascular Closure Device for use in certain cardiac ablation procedures.
