Federal Register notice: FDA corrects a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entitled Studies to Evalu...
CDRH Digital Health Center of Excellence director Troy Tazbaz says that developing a medical device quality assurance practice for artificial intellig...
Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patients failed to meet t...
FDA posts a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.
Federal Register notice: FDA announces a proposed administrative order to require a warning on Over-the-Counter Internal Analgesic, Antipyretic, and A...
Teleflex and subsidiary Arrow International recall (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic...
Getinge recalls (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within the vaporizer.
