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U.S. Department of Health and Human Services

For Industry

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Annual Reports and Plans


The Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan is a 5-year plan that describes how the Food and Drug Administration (FDA) proposes to meet IT goals of the GDUFA Authorization Performance Goals and Procedures Fiscal Years 2013 through FY 2017.


This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.