Business · 13/08/2021Updated: 10/17/2026 · 1 min read

FDA Establishes Public Docket for Post-Approval Drug Regulation Comments

Summary

The FDA is seeking public input on post-approval regulation of certain pre-Hatch-Waxman drug products approved in abbreviated applications, which were previously overseen by the Office of Generic Drugs.

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

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