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The Food and Drug Administration Amendments Act of 2007 (FDAAA) mandated the Food and Drug Administration (FDA) to establish an active postmarket risk identification and analysis system. In response, the FDA established the Sentinel Initiative. A core program of the Sentinel Initiative is the Sentinel System, a national medical product safety surveillance system that includes one of the largest healthcare insurance claims data-based multisite distributed databases dedicated to medical product safety.
This report covers activities and accomplishments of the Sentinel System from January 1, 2022, through December 31, 2024. This assessment report fulfills the Prescription Drug User Fee Act (PDUFA) VII commitment to “analyze, and report on the use of Sentinel for regulatory purposes.” This commitment is one of seven aimed at maintaining the Sentinel Initiative capabilities and continuing integration into FDA’s drug safety activities.