FDA-TRACK: Generic Drug User Fee Amendments Historical Performance - Generic Drug Applications and Supplements

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Generic Drug Applications and Supplements

Program Enhancement Goals (Procedural)

Meeting Management

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • 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

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:

•   * Performance is currently preliminary due to pending submissions.