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  1. Generic Drug User Fee Amendments

GDUFA II Enhanced Accountability & Reporting

In order to promote accountability and transparency, GDUFA II included provisions so that industry and public stakeholders are able to observe the Agency’s productivity and performance with generic drug reviews under GDUFA II. Please note GDUFA III began in October 2022.

The links below provide data on GDUFA II metrics:

GDUFA II Activities Reports

Additional Reports

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