How Will FDA Real-World Data Guidances Affect Patient Advocacy Groups?

December 5, 2022

With the US Food and Drug Administration’s (FDA) growing focus on the use of real-world data (RWD) and real-world evidence (RWE) in decision-making, patient advocacy groups must adapt to the new regulatory landscape. Fortunately, the guidances contain information to guide advocacy organizations in setting up and managing their patient registries.

According to James Skipper, “To successfully utilize registry data in drug submissions, the FDA released this draft guidance to provide recommendations on evaluating the relevance and reliability of a potential registry partner. Also included are several considerations for linking registry data to other sources to provide supplemental information, including EHRs, digital health technologies, and other registries.”

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