GDUFA was enacted into law on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). GDUFA was based on an agreement between FDA and the human generic drug industry, codified by Congress, to accelerate the delivery of high-quality, lower-cost human generic drugs. FDASIA authorized GDUFA for a 5-year period from October 1, 2012, through September 30, 2017. Each iteration of GDUFA has covered a five-year period. On August 18, 2017, the President signed into law the FDA Reauthorization Act of 2017 (FDARA) which included the Generic Drug User Fee Amendments of 2017 (GDUFA II).
GDUFA I (2012 to 2017)
GDUFA I enabled FDA to administer critical and measurable enhancements to the performance of the human generic drugs program and bring greater predictability and timeliness to the review of human generic drug applications. A critical component of GDUFA I was to expedite the review and approval of human generic drugs. It also established equivalency between domestic and foreign manufacturers providing human generic products to American consumers by ensuring that all facilities, located anywhere in the world, are inspected with comparable depth and rigor using risk-based approaches.
GDUFA II (2018 – 2022)
Under GDUFA II, FDA continues to modernize the generic drug program by improving the program’s efficiency, quality, and predictability. With the ultimate goal of increasing consumer access to safe, high quality and affordable generic drugs, GDUFA II focuses on 2 major objectives: (1) reducing the number of review cycles to approval and (2) increasing the approvals of safe, high quality lower cost generic drugs. The program now has different review goals for priority applications and more communications touchpoints with industry. GDUFA II establishes a well-organized process to review complex generic drug products more efficiently. This approach allows FDA to work closely with the generic drug industry. By allowing earlier and more frequent meetings between FDA and an applicant, challenges that arise during the development these products can be forecasted and addressed in an efficient and effective manner.
Annual performance reports are prepared by FDA's Office of Planning in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
For additional information on these reports, please contact:
Office of Planning and Evaluation
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
GDUFA Performance Reports
Performance reports for previous years are available in the FDA Archive.