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Generic Drug User Fee Guidance - Assessing User Fees - USFDA

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year period from persons that submit certain abbreviated new drug applications (ANDAs) for review or that are referenced in certain ANDAs.

Fees authorized by this legislation have played an important role in bringing greater predictability and timeliness to the review of generic drug applications.

GDUFA II extends FDA’s authority to assess and collect user fees for FY 2018 through FY 2022 and revises the fees that the Agency collects and how it collects some fees.

This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017.

GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

This guidance describes the types of user fees authorized by GDUFA II, the process for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment.

This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees and FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes.

Click on the LINK to know more about this guidance on investigatingOut-of-Specification (OOS) Test Results for Pharmaceutical Production.


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