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Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration

Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration

Figure 1 provides an overview of the ICSR evaluation workflow (Figure 1 is adapted from the study by Ball and Dal Pan [8]. Case definitions are a set of prespecified criteria for determining whether a patient should be identified as having a particular disease, injury, or other health condition (ie, AE) [2]).

Robert Ball, Andrew H Talal, Oanh Dang, Monica Muñoz, Marianthi Markatou

J Med Internet Res 2024;26:e50274