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FDA to Support Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making

December 14, 2022

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A new funding opportunity from FDA has been established for projects to further promote the potential use of real-world data (RWD) to generate real-world evidence (RWE) related to drug development. FDA hopes to encourage more projects that address these types of gaps in knowledge that can limit the use of RWD and RWE.

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation. FDA encourages a variety of projects that are applicable to drugs and biologics, excluding devices.

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