Draft Guidance on Implementing GDUFA II By FDA

The US FDA revised draft guidance on the generic drug user fee program (GDUFA II) which serves the new fee structure and types of fees will be assessed.

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. Because 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. FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes. This guidance does not address how FDA determines and adjusts fees each fiscal year, nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Biosimilar Biological User Fee Amendments). Throughout this guidance, references to user fees or the user-fee program indicate generic drug user fees collected under section 744B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance revises and replaces FDA’s draft guidance for industry Assessing User Fees Under the Generic Drug User Fee Amendments of 2017, published in October 2017.

“A facility no longer incurs a fee if it is only referenced in pending generic drug submissions because the facility fee obligation now applies only to facilities referenced in approved generic drug submissions,” FDA explains, also noting how contract manufacturing organizations pay one-third the amount of the facility fee incurred by FDF facilities.

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