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.
GDUFA Financial Reports
GDUFA requires the FDA to report annually on the financial aspects of its implementation.
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.