FDA announces a 1/26/2023 Webinar entitled FDAs Labeling Resources for Human Prescription Drugs that will discuss new resources available for the phar...
FDA updates a Web page it maintains on Medtronic recalls involving its HeartWare Ventricular Assist Device system that is intended to enhance user acc...
Federal Register notice: FDA corrects a 9/28 notice entitled Statement of Organization, Functions, and Delegations of Authority that discussed a reorg...
FDA clears a Zimmer Biomet 510(k) for the Persona OsseoTi Keel Tibia for cementless knee replacement.
FDA has approved a Jazz Pharmaceuticals supplemental BLA to add a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparaginase erwin...
Federal Register notice: FDA announces a 12/8 Science Board to the FDA Advisory Committee meeting that will hear research needs for evaluating oral ca...
FDA extends by three months the review of a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoie...
FDA asks for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of its Trilogy ventilat...
