U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 May 2023

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821.

Back to Top