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Zdrowie i gospodarka · 11/01/2024

FDA Releases Draft Guidance for Reconsideration of Generic Drug User Fee Amendments Requests

The FDA has released a draft guidance for industry on procedures for requesting reconsideration of generic drug applications, updating the 2017 guidance to reflect the latest reauthorization of the Generic Drug User Fee Amendments.

Source: Federal Register — Food and Drug AdministrationOpen original release →