Leveraging Real-World Evidence: A Paradigm Shift in Regulation
Sugato De, Leanne R. Larson, KIM L. KELLY, Beate Hanson et autres
SUMMARY: The study methodology and regulatory frameworks for real-world data collection is quickly evolving, opening new avenues to use valid and robust real-world evidence (RWE) to support regulatory decision making. Although the Food and Drug Administration has historically accepted specific applications of …
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7 citations
Journal of Orthopaedic Trauma