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  1. Generic Drug User Fee Amendments

GDUFA Guidances and MAPPs

This page provides quick access to guidances for industry and sections of the FDA Manual of Policies and Procedures (MAPP) related to GDUFA.

GDUFA Guidance for Industry

To view all GDUFA guidances, go to the Guidances for Drugs page, enter “GDUFA” in the search box, and under “Filter by,” choose “Generic Drugs” as the Topic.


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