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Business · 21/09/2011Updated: 10/17/2026 · 1 min read

FDA Releases Revised Guidance on Marketed Unapproved Drugs

Summary

The Food and Drug Administration (FDA) has announced the availability of a revised guidance document outlining its approach to enforcing regulations on unapproved new drugs sold in the US market, with changes effective for drugs introduced after September 19, 2011.

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

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