US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience

Advances in the availability and analysis of real‐world data (RWD) have enabled the generation of robust real‐world evidence (RWE) to support regulatory decision making by the US Food and Drug Administration. Realizing the full potential of RWE in a regulatory environment requires cross‐discipline expertise and collaboration to increase confidence in RWE‐based approaches. The FDA's Advancing RWE Program was established to address this need by providing a new option for regulatory interactions on RWE‐based approaches.