GDUFA Performance Reports
On September 30, 2022 the President signed into law the FDA User Fee Reauthorization Act of 2022 (FUFRA), which included the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for 5 additional years (FY 2023 through FY 2027 referred to as GDUFA III). GDUFA provides FDA with revenue to speed up the delivery of safe and effective generic drugs to the public, improve the predictability of the review process and ensure the financial stability of the FDA generic drug program.
GDUFA I (2012 to 2017)
GDUFA I established the generic drug program that enabled FDA to administer critical and measurable enhancements to bring greater predictability and timeliness to the review of human generic drug applications. A critical component of GDUFA I was to establish assessment timelines that 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 continued 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 focused 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 created review goals for priority applications and more communication touchpoints with industry. GDUFA II also established a well-organized process to review complex generic drug products. Through earlier and more frequent meetings between FDA and an applicant, FDA can work closely with the generic drug industry to forecast and address challenges that arise during the development of complex generic drug products in an efficient and effective manner.
GDUFA III (2023 - 2027)
GDUFA III builds on the successes of GDUFA I and GDUFA II and provides several enhancements to the generic drug program including a focus on maximizing the efficiency and utility of each assessment cycle, with the intent of reducing the number of assessment cycles for generic drug applications and facilitating timely access to quality, affordable, safe, and effective generic medicines. GDUFA III continues to foster the development, assessment, and approval of complex generic drugs through new program enhancements and also provides a solid financial foundation to support the generic drug program through a new annual capacity planning adjustment.
Annual performance reports are prepared by FDA's Office of Planning, Evaluation and Risk Management 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, Evaluation and Risk Management
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541
GDUFA Performance Reports
Performance reports for previous years are available in the FDA Archive.