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Business · 10/02/2009Updated: 10/17/2026 · 1 min read

FDA Withdraws Direct Final Rule on Authorized Generic Drugs Due to Adverse Comments

Summary

The Food and Drug Administration (FDA) has withdrawn a direct final rule requiring annual reports on authorized generic drugs after receiving significant adverse comments, following the publication of the rule in the Federal Register on September 29, 2008.

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

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