FDA Launches Real-World Evidence Program, Part of PDUFA VII Commitments

The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development, according to Kimberly Smith, RWE analyst in CDER’s Office of Medical Policy.

Speaking in a presentation at the FDA’s Regulatory Education for Industry (REdI) Annual Conference, June 5-9, Smith explained that the program launched in October 2022 as part of the agency’s commitments under the Prescription Drug User Fee Act (PDUFA VII), the program aims to identify approaches for generating RWE that can meet regulatory submission requirements.

Under PDUFA VII, the agency agreed to create the program by December 2022 and then to report aggregate data on an annual basis starting June 30, 2024, including data sources, study designs and the types of regulatory requests.

Smith explained that at the end of the four program meetings “the goal is to have a generally agreed-upon plan” and that the sponsor “will continue on with the usual pathways” for interactions with the agency’s review division.

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