For Industry
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GDUFA Legislation and Background
The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. This section includes background information on GDUFA.
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Legislation
- Generic Drug User Fee Amendments of 2012; Pub. L. 112-144, Title III
- FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act
- GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99KB)
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Background
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