FDA-TRACK: Generic Drug User Fee Amendments Program Enhancement Goals (Procedural) Summary

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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.

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Footnotes:

• * As described in Section III.B of the GDUFA III Commitment Letter, the maximum number of suitability petitions to which FDA commits to review and respond increases each year of GDUFA III.