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  1. Generic Drug User Fee Amendments

GDUFA Annual Reports and Plans

GDUFA Performance Reports

The Generic Drug User Fee Amendments of 2012 (GDUFA) requires the Food and Drug Administration (FDA) to report annually on FDA’s accomplishments and outline expectations for the future.  These reports are available for download on the GDUFA Performance Reports page.

GDUFA Financial Reports

GDUFA requires the FDA to provide annual financial reports to Congress regarding the program activities, collections, and spending of the Generic Drug User Fee Amendments. These reports are available for download on the GDUFA Financial Reports page.

GDUFA Information Technology/Informatics Plan

The GDUFA Information Technology (IT) Plan is a five-year plan that describes how the FDA proposes to meet IT goals of the GDUFA Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017.