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BioWorld - Saturday, December 27, 2025
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» FDA’s real-world evidence draft expands data requirements
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FDA’s real-world evidence draft expands data requirements
Jan. 30, 2024
By
Mark McCarty
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
Regulatory
U.S.
FDA