One of the areas FDA is committed to enhancing and modernizing is the FDA drug safety system, in part through the optimization of the Sentinel Initiative. FDA has a series of commitments under PDUFA VII to maintain Sentinel Initiative capabilities and continue to integrate into FDA drug safety activities. This report fulfills one of those commitments: to analyze and report on the use of Sentinel for regulatory purposes by the end of fiscal year 2025.

This report was prepared by the Sentinel Operations Center in collaboration with the FDA. The report covers the activities and achievements of the Sentinel System in the period from 2022 to 2024, described in the following sections: 1) Introduction: Sentinel System Overview, 2) The FDA’s Utilization of Sentinel System, 3) Improving the Sentinel System: Integrating Electronic Health Record (EHR) Data Within a Causal Analysis Framework, and 4) Public Accessibility and Communications. Previous activities and achievements of the Sentinel System are described in the report “Assessment in Support of the Sentinel System” developed in response to a PDUFA VI commitment.

The report can be accessed via the link below.

 

Report 
An Assessment of the Sentinel System (2022 to 2024).