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Business · 27/09/2011Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on User Fee Waivers for Drug and Biological Products

Summary

The Food and Drug Administration (FDA) has made available a new guidance document that provides recommendations for applicants considering user fee waivers, reductions, or refunds for drug and biological products, replacing a previous draft guidance from July 16, 1993.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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