FDA-Advancing Real World Evidence Program


FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements. The Advancing RWE Program fulfills an FDA commitment under PDUFA VII, incorporated as part of the FDA User Fee Reauthorization Act of 2022.


The Advancing RWE Program the opportunity to meet with Agency staff—before protocol development or study initiation to discuss the use of RWE in medical product development.

The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage with the Agency will continue to be available.

Meetings will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027.

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

Goals of the Advancing Real-World Evidence Program

  • Identify approaches for generating RWE that meet regulatory requirements in support of labeling for effectiveness.
  • Meeting post-approval study requirements;
  • Develop agency processes that promote consistent decision-making and shared learning regarding RWE;
  • Promote awareness of characteristics of RWE that can support regulatory decisions by allowing FDA to discuss study designs considered in the Advancing RWE Program in a public forum.

Learn More about Real-World Evidence

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