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Zdrowie i gospodarka · 3.03.2004

Generic Drug Issues; Request for Comments

The Food and Drug Administration (FDA) is requesting public comments on whether additional regulatory actions should be taken concerning the approval of abbreviated new drug applications (ANDAs). The agency is asking for comments because of recent statutory changes. The agency is not proposing any regulatory changes in this notice. The purpose of this notice is to identify a number of issues that the agency would like interested persons to address and to give interested persons an opportunity to submit comments on possible actions.

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