FDA announces submission deadlines for meeting opportunities within the Advancing Real-World Evidence Program

The FDA has set the first deadline of March 31, 2024 for any sponsors looking to discuss the use of real-world evidence (RWE) in medical product development under the Advancing Real-World Evidence (RWE) Program.

As previously reported on The Evidence Base, the Advancing Real-World Evidence (RWE) Program was established in October 2022 as a first step by the FDA to meet their commitments under PDUFA VII. The goal of the program is 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.”

Through the program, sponsors can request a meeting with the FDA to discuss incorporating RWE in their product development plans before drafting the study protocol or initiating any clinical studies. The FDA expects RWE to be used to provide regulatory-grade evidence supporting new therapeutic indications, expanded populations, labelling expansion and dosing changes. Meetings can also be requested where RWE will be used to satisfy post-approval study requirements.

Meeting requests will be selected by the agency based on their “potential regarding fit-for-use data, adequate study design, and appropriate regulatory conduct.” Whilst any eligible RWE will be considered, the FDA has stated they will prioritize certain requests, such as those fostering diversity in data sources, study designs, analytical approaches, and regulatory indications.

To promote ‘shared learning’ on the use of RWE in regulatory decision making, the FDA may discuss the study designs considered within the framework of the Advancing RWE Program in a public setting.

In 2024, there will be two submission cycles with application deadlines of March 31 and September 30, 2024. The FDA will accept one to two primary meeting requests (and potentially up to two alternative requests) per submission cycle. From 2025 onwards, as the program develops additional meeting requests per submission cycle will be considered.

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• How the FDA are using real-world evidence in regulatory decision-making: an interview with Nicholaas Honig, Aetion
• PDUFA VII and the FDA Advancing Real-World Evidence Program: an interview with Lucy Vereshchagina, PhRMA
• Infographic: Milestones in the FDA’s Real-World Evidence activities