FDA Grand Rounds - Advancing Real World Evidence in FDA Regulatory Decision Making
FDA Grand Rounds — Office of Medical Policy, Center for Drug Evaluation and Research · February 5, 2026
Dr. Marie Bradley of FDA’s Office of Medical Policy presented on the agency’s real‑world data and evidence (RWD/RWE) programs, described a multi‑part FDA‑funded RCT‑duplicate demonstration project that found many claims‑data emulations produce similar conclusions to randomized trials, and reviewed program processes, guidance, and limits.
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