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PDUFA VI Commitment: Assessment in Support of Sentinel System

FDA is committed to enhancing the U.S. drug safety system and envisions the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA agreed to an expanded set of commitments related to scaling up and expanding Sentinel while continuing to embed its use in FDA’s operations. This set of commitments requires that by the end of fiscal year (FY) 2022, FDA assess the Sentinel program’s integration into regulatory decision-making.

FDA contracted a third-party advisor to conduct this assessment of Sentinel in accordance with its PDUFA VI commitments. This assessment provides an analysis of FDA’s achievement of three core initiatives for Sentinel including (1) expanding Sentinel’s breadth of available data; (2) advancing Sentinel’s data analysis and methods capability; and (3) facilitating communication and engagement opportunities to increase use and awareness of Sentinel’s value. This assessment concludes with a summary of Sentinel’s ongoing and planned activities during its current contract period to further embed its use in FDA regulatory decisions. FDA’s assessment indicates Sentinel continues to deliver value both within and beyond its mandated mission.

The full assessment report can be accessed using the link below.


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