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Business · 29/04/2010Updated: 10/17/2026 · 1 min read

FDA Publishes Draft Guidance on Section 513(g) Requests for Information

Summary

The Food and Drug Administration (FDA) has released a draft guidance document outlining procedures for requesting information under the Federal Food, Drug, and Cosmetic Act, specifically for Section 513(g) requests, and is seeking feedback from industry and FDA staff.

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

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