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Business · 09/05/2025Updated: 10/17/2026 · 1 min read

FDA Publishes Final Report on Communication Through Product Quality Information Requests

Summary

The FDA is releasing a final report on its assessment of communication with applicants during product quality information requests, as part of its commitment under the reauthorized Prescription Drug User Fee Act (PDUFA). The agency is now soliciting public comments on the report.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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