FDA launches Real-World Evidence Program

The U.S. FDA recently issued several guidances relating to Real-World Evidence /-Data (e.g. How to Submit Documents with Real-World Data to FDA, Real-World Data). Now the agency 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. For selected product sponsors, the Program provides the opportunity to meet with FDA staff in CDER /  CBER - before protocol development or study initiation - to discuss the use of RWE in medical product development. However, "the Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage the agency will continue to be available".

Goals of the RWE Program

The Advancing RWE Program is designed to:

  • Identify approaches for generating RWE for effectiveness labeling (e.g., new indications, populations, dosing information) or for meeting post-approval study requirements,
  • Develop agency processes that promote consistent decision-making and shared learning regarding RWE,
  • Promote awareness that RWE can support regulatory decisions.

Sponsors may submit an initial meeting request to the Advancing RWE program on a rolling basis through March 31, 2027. FDA will review all meeting requests received in the preceding 6-month submission cycle after each submission deadline.

More information on the program is available on FDA´s Advancing Real-World Evidence Program webpage.

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