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Zdrowie i gospodarka · 16.04.2013

Generic Drug Facilities, Sites, and Organizations

The Food and Drug Administration (FDA) is announcing that the generic drug facility self-identification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites, and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually.

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