Federal Register notice: FDA sends to OMB an information collection revision entitled Investigational New Drug Application Requirements.
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices; Device Tracking 21 CFR Part 821.
FDA warns six overseas manufacturers of over-the-counter drugs about CGMP violations.
CBER begins a phased implementation of in-person industry meetings with device manufacturers.
The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial intelligence and ma...
Novo Nordisk says its Wegovy cut the risk of major adverse cardiovascular events by 20% in overweight or obese adults in the SELECT trial.
FDA approves a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation.
FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.
