Issue Date: May 1, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): User Fees,
Status: Final
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022
This guidance provides information to stakeholders regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) under Title I of the FDA User Fee Reauthorization Act of 2022. Because PDUFA VII created changes to the user fee program, this guidance explains the changes created by the statute which includes changes to certain definitions, changes to certain PDUFA fee exceptions, waivers, exemptions, reductions, and returns and certain changes for PDUFA invoicing procedures.
Download the Guidance Document
