Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
Conclusion and Summary
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Self-Identification

GDUFA requires that human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA.

This information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs, setting annual facility fee amounts and targeting inspections
(Note that not all firms that self-identify are required to pay a fee).

Close up of hand holding a card that says, "Self Identify."
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