FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews - fda.gov

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews - fda.gov
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For Immediate Release: December 15, 2025 The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications revi… [+2340 chars]

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