Docket Number:
FDA-2017-D-5913
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides stakeholders information regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017. Because PDUFA VI created changes to the user fee program, this guidance explains the new fee structure created by the statute, and the types of fees for which entities are responsible.

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All written comments should be identified with this document's docket number: FDA-2017-D-5913 .