Pharmacovigilance in Practice From Safety Signals to Regulatory Action 1080

Why It Matters

Understanding DPV’s structured, multi-source approach and the NIS framework clarifies how the FDA prioritizes and escalates postmarket safety concerns, affecting clinicians, manufacturers and patients and shaping regulatory actions and labeling. Timely, accurate adverse-event reporting into FAERS directly influences the detection of safety signals and potential regulatory interventions.

Summary

FDA Grand Rounds presenters from the Center for Drug Evaluation and Research’s Division of Pharmacovigilance (DPV) outlined how the agency conducts postmarket drug safety surveillance, defining pharmacovigilance and the criteria for safety signals. They described DPV’s team structure aligned to therapeutic areas, the 2020 National Identification of Safety Signals (NIS) process with its pre-evaluation, evaluation and action phases, and the multiple data sources used—most notably the FDA Adverse Event Reporting System (FAERS) and complementary literature, epidemiologic, foreign regulator, and nontraditional data. Speakers emphasized that FAERS ingests over 2 million adverse event reports annually (with most submitted by manufacturers) and detailed how evaluators systematically triage reports to determine when formal regulatory action is warranted. The session also previewed three high-profile safety updates and guidance for submitting adverse event reports to help detect future signals.