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Article Abstract
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.
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| http://dx.doi.org/10.1002/cpt.3700 | DOI Listing |
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