Pharmacovigilance in Practice From Safety Signals to Regulatory Action 1080
FDA Grand Rounds: Pharmacovigilance in Practice — From Safety Signals to Regulatory Action · June 10, 2026
FDA Grand Rounds presentation on pharmacovigilance by Division of Pharmacovigilance (DPV) staff, covering DPV methods, FAERS data use, and three recent safety signals that led to labeling changes, a CDER safety alert, and warning letters; presenters described how to submit MedWatch reports.
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