PDUFA V Commitment: Assessment of Sentinel System’s Strengths, Limitations, and Appropriate Use
FDA is committed to enhancing and modernizing the U.S. drug safety system and envisions that the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA agreed to a set of commitments to continue the development and implementation of the Sentinel System. This set of commitments includes interim and final assessments that evaluate the strengths, limitations and the appropriate use of Sentinel for informing regulatory actions by FY 2015 and FY 2017, respectively.
FDA contracted a third-party advisor to conduct these interim and final assessments of Sentinel in accordance with its PDUFA V commitments. These assessments provide a longitudinal view of how Sentinel has evolved since the initial five-year pilot, launched in 2009, through its first year of scientific activity after transitioning to the fully operational Sentinel System in February of 2016. The final assessment reports on impressions of Sentinel collected from dozens of interviews of staff within the FDA, the Sentinel Operations Center, and at the Data Partners. The evaluation offers an in-depth analysis of the progress towards developing a modern risk identification and analysis platform for FDA-regulated drugs, biologics, and devices. The full interim and final assessment reports can be accessed using the links below.