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Drugs
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User Fees
| Title and Format | Type | Issue Date |
|---|---|---|
| Attachment G -- Draft Interim Guidance Document for Waivers of and Reductions in User Fees (PDF - 897 KB) | Draft | 7/16/1993 |
| Classifying Resubmissions in Response to Action Letters (PDF - 76 KB) | Final | 5/14/1998 |
| Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (PDF - 48 KB) | Final | 6/1999 |
| Guidance for Industry and FDA Staff: Application User Fees for Combination Products (PDF - 83 KB) | Final | 4/2005 |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27 KB) | Final | 11/2001 |
| Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 211 KB) | Final | 12/30/2004 |
| User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (PDF - 46 KB)(Issued , Posted 2/7/2007) |
Final | 2/7/2007 |
Also see Current Good Manufacturing Practice Regulations
Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
(Posted 8/11/1997)
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