|Project Title||PDUFA V Commitment: Sentinel Program Interim and Final Assessments|
Wednesday, September 27, 2017
FDA contracted a third-party advisor to conduct these interim and final assessments of Sentinel in accordance with its Prescription Drug User Fee Act (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 above.
- Vaccines, Blood & Biologics
- Devices and Radiologic Health