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FDA Solicits Feedback on Drug Products Approved Under Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments

The FDA has established a   public docket   to solicit comments on several issues related to FDA’s regulation of certain drug products approved under abbreviated new drug applications before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.

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