Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference

FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes.

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