Washington, D.C. (October 15, 2024) – The RWE Alliance issued the following statement applauding the U.S. Food and Drug Administration (FDA) for reaching a major milestone in its RWE Program by recently finalizing guidance required by the 21st Century Cures Act:
“The RWE Alliance is pleased that the Agency has now finalized the core suite of guidance directed by the 21st Century Cures Act, including on the use of real-world data derived from electronic health records, medical claims, and registries, as well as on the topics of data standards and considerations for regulatory submissions containing RWD/E. The final guidances benefit patients and provide drug sponsors, as well as data and analytics organizations, more clarity on the Agency’s expectations for submissions including or relying on RWE.
“The RWE Alliance provided comments and suggestions on each draft guidance issued under FDA’s RWE Program. We commend the Agency for making positive changes across the final guidances, reflecting FDA’s increasing experience with RWE in regulatory submissions and commitment to realizing the full potential of RWE for patients.
“We look forward to continuing to work with FDA as the Agency works to further operationalize and implement the RWE Program, as well as an “evidence-ready system” for RWE. FDA should continue to account for the unique nature of RWD and myriad potential RWD sources while maintaining the Agency’s important evidentiary standards. We encourage FDA to continue highlighting the value that RWD/E can bring to medical product development, such as by raising greater awareness about current and potential uses for RWE. With ongoing collaboration, FDA, international health authorities, and the broader RWE ecosystem can build upon the Agency’s RWE Program guidance to accelerate evidence generation using novel data sources to ultimately benefit patients.”
About RWE Alliance
The RWE Alliance is a coalition of real-world data and analytics organizations with a common interest in harnessing the power of real-world evidence to inform regulatory decision making to improve the lives of patients.
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info@rwealliance.org