An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Prescription Drug User Fee Amendments

Guidance Documents and MaPPs (PDUFA)

MaPPs (Manual of Policies and Procedures)

MAPP 6050.1 Rev.2 Effect of Failure to Pay PDUFA Fees, Issued 12/3/2021

Guidance Documents

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 462KB) (posted 10/18/19)
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief (PDF - 331 KB) (posted 6/6/18)
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDF - 96KB) (posted 11/9/20)
Application User Fees for Combination Products. (5/3/2005)
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 212KB) (1/3/2005)

Back to Top

Top