Drugs

FDA Touts Sentinel Successes

FDA has issued a report, “An Assessment in Support of the Sentinel System (2022 to 2024),” highlighting the Sentinel System’s activities and achievements in the study period. The report fulfills one of the commitments in the Prescription Drug User Fee Act VII reauthorization letter to maintain Sentinel initiative capabilities and continue to integrate it into agency drug safety activities.

The report says Sentinel was focused on these areas:

expand Sentinel data infrastructure;
improve Sentinel data analysis capability;
facilitate transparent communication and engagement opportunities;
respond to FDA efforts to develop real-world evidence;
build a modern system relying on the electronic health records from some 10 million lives;
enhance Sentinel as a national resource; and
support FDA’s public health mission.

The report lists these areas of progress:

Sentinel has met and far exceeded its FDA Amendments Act requirement to maintain a network with access to at least 100 million patient lives;
Sentinel supports FDA’s mission to protect the public’s health by helping to ensure drug safety;
FDA launched in 2019 a five-year strategy for the Sentinel System to guide investments in emerging data science disciplines;
the Sentinel Innovation Center brings together experts from FDA, academia, clinical medicine, and industry to inform the meaningful use of electronic health records for regulatory decision-making;
Sentinel has increased the richness and use of supplemental data sources, including electronic health records;
consistent with the five-year strategy, FDA envisions Sentinel as a national resource;
FDA continues to explore methods to expand the breadth of safety concerns that Sentinel can address; and
Sentinel has been the focus of a substantial number of opportunities to improve and sustain sponsor and public outreach and engagement.

“Sentinel has made substantial progress in developing methods and data linkages, testing, and incorporating novel technologies for more efficient performance, enhancing the use of real-world data for evaluating medical product safety, and disseminating knowledge to advance regulatory science,” the report concludes. “Sentinel continues to deliver value both within and beyond its mandated mission.”

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