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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 5/3/18)
Application User Fees for Combination Products. [Federal Register Notice or (PDF - 50KB)] (5/3/2005)
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 212KB) (1/3/2005)

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