FDA announces initiation of the Advancing Real-World Evidence Program to support regulatory decision-making
The Advancing Real-World Evidence Program, initiated following reauthorization of PDUFA VII, will provide sponsors with the opportunity to meet with the FDA to discuss the use of RWE in medical product development before protocol development or study initiation.
As documented in the Federal Register on 20th October 2022, the US Food and Drug Administration (FDA) have announced the commencement of a new program to support their commitment to advancing the appropriate use of RWE and RWD in regulatory decision-making. Following reauthorization of the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), the Advancing Real-World Evidence (RWE) Program will seek to ‘identify approaches for generating RWE that meet regulatory requirements in support of labeling for effectiveness (e.g., new indications, populations, dosing information) or for meeting post-approval study requirements’.
The Advancing RWE Program is an optional pathway for sponsors to carry out during the regulatory process and sponsors must apply to take part in the program. Based on a specific criteria, the FDA will select eligible applications and invite the sponsors to participate in the program, providing them with the opportunity to meet with Agency staff to discuss approaches for generating RWE that can meet regulatory requirements. A long-term program, meetings under the Advancing RWE Program will be undertaken from 2023 until 2027.
To foster shared learning around the various types of data sources and study designs used to generate RWE and help increase understanding of how RWE can be used in regulatory decisions, the FDA may present study designs considered in the Advancing RWE Program as case studies in a public forum.
Additional goals of the initiative, outlined on the Advancing RWE Program website, include supporting the development of processes to be used by the FDA that promote consistent decision-making and shared learning regarding RWE.
Full details on the Advancing RWE Program, including details on how to participate and timelines, can be found on the website here https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program
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