Evolving FDA guidance on the application of RWD/RWE

Since the 21st Century Cures Act in 2016 and subsequent FDA guidance, regulatory frameworks have evolved to incorporate RWD and RWE - allowing a broader set of data sources, including electronic health records (EHRs), claims, and registries, to be considered for regulatory decision making. In this white paper, explore key learnings about RWD/RWE in regulatory submissions, including:

Implications from 2016’s 21st Century Cares Act and subsequent FDA guidance
Benefits and considerations for using RWD/RWE in externally controlled trials (ECTs)
Best practices to meet FDA requirements when using RWD/RWE in regulatory submissions
4 case studies to illustrate the FDA’s approach in evaluating RWD/RWE

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