This FY 2014 GDUFA Performance Report covers the period of October 1, 2013, through September 30, 2014. As required under GDUFA, this report presents FDA’s accomplishments for the second year of GDUFA and outlines our goals for the future.
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.
The Generic Drug User Fee Amendments (GDUFA) of 2012 requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation. Required under GDUFA, this report covers activities for fiscal year (FY) 2013.