FDA-TRACK: Generic Drug User Fee Amendments Review Goals 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:

• * Section I(A) of the GDUFA III Commitment Letter.
• † Section I(B) of the GDUFA III Commitment Letter.
• ‡ Section I(C) of the GDUFA III Commitment Letter.
• § The GDUFA III Commitment Letter specifies that the reporting of unsolicited amendments submitted during the review cycle and unsolicited amendments submitted between review cycles should be performed separately. For the efficient treatment of these amendments, they are combined in this dashboard.
• ¶ For CC that raises an issue that relates to one or more pending citizen petitions, the 60- or 120-day time frame starts on the date FDA responds to the petition (if there is only one petition) or the last pending petition.