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FDA Announces Final Report on Communication Through Product Quality Information Requests, Seeks Public Comments
May 09, 2025
WASHINGTON, May 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has made available the "Product Quality Information Request Communications Assessment: Final Report," a key document resulting from the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).

This final report aims to evaluate and enhance communication practices between the FDA and drug applicants during the application review process, specifically f . . .

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