FDA-TRACK: Generic Drug User Fee Amendments (GDUFA) Performance Dashboards

 

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Relevant Links:

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

First enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA User Fee Reauthorization Act of 2022, reauthorizes FDA to assess and collect fees for generic drug products from October 2023 through September 2027. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process.

The Generic Drug User Fee Performance Dashboards (GDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated GDUFA Performance Report to Congress for the Generic Drug User Fee Amendments (the Report). The GDUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. 

 

Data Dashboards to be added.