The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions and become an established resource for real-world data (RWD), according to a new assessment.
The assessment, which was conducted by a third-party advisor, is required as part of the agency’s commitments under the Prescription Drug User Fee Act (PDUFA) VI. It spells out the Sentinel System’s progress in expanding its data infrastructure and data analysis capability, as well as its contribution to real-world evidence generation. This is the third assessment of the Sentinel System since it was created by FDA in 2008 (RELATED: Sentinel: FDA Outcomes Five-Year Roadmap, Regulatory Focus 09 January 2019).
“Sentinel has made substantial progress in developing methods and data linkages, testing, and incorporating novel technologies for more efficient performance, enhancing the use of RWD for evaluating medical product safety, and disseminating knowledge to advance regulatory science,” according to the assessment. “Sentinel continues to deliver value both within and beyond its mandated mission.”…
