19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an Advancing Real-World Evidence Program.

The program seeks to improve the quality and acceptability of real world evidence based approaches in support of new intended labelling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements. 

The Advancing RWE Program fulfils an FDA commitment under PDUFA VII, incorporated as part of the FDA User Fee Reauthorization Act of 2022.

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