FDA-TRACK: Generic Drug User Fee Amendments (GDUFA) Quarterly Performance Dashboards – Historical Applications and Supplements

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Generic Drug Applications and Supplements

Current Performance

Historical Performance

Goals Summary

Relevant Links:

1. • GDUFA III Commitment Letter
2. • Generic Drug User Fee Amendments
3. • FDA User Fee Reauthorization Act of 2022
4. • FDA-TRACK: GDUFA Performance Reports
5. • FDA-TRACK: CDER Generics Dashboard
6. • FDA-TRACK: GDUFA Annual Performance Dashboards

GDUFA was enacted on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), and was most recently reauthorized on September 30, 2022, extending the program through September 30, 2027. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA's generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications.

Download GDUFA Historical Performance: Generic Drug Applications and Supplements Dataset

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Footnotes:

1. * FY 2025 and FY 2026 include preliminary performance as of 3/31/2026.
2. GDUFA II performance goals and commitments are applicable to FY 2018 - FY 2022.
3. GDUFA III performance goals and commitments are applicable to FY 2023 - FY 2027.