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

• PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR (Posted 08/04/2023)

• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 (PDF - 386 KB) (posted 5/1/2023)

• Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 462KB) (posted 10/18/19)

• Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 (PDF - 96KB) (posted 11/9/20)

• Application User Fees for Combination Products.  (7/16/2024)

• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 212KB) (1/3/2005) 

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