Guidance Documents and MaPPs (PDUFA)
MaPPs (Manual of Policies and Procedures)
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MAPP 6050.1R, Refusal to Accept Application for Filing From Applicants in Arrears (PDF - 29KB), Issued 8/14/2007
Guidance Documents
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Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 462KB) (posted 10/18/19)
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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)
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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)