About FDA
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FY 2010 AGDUFA Financial Report
Animal Generic Drug User Fee Act of 2008
Food and Drug Administration
Department of Health and Human Services
June 2011
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Printable Version of FY2010 AGDUFA Financial Report
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Table of Contents
- Executive Summary
- Background
Meeting the Legal Conditions for User Fees in FY2010 FY2010 User Fee Collections FY2010 User Fee Obligations FY2010 Carryover Balances - FY2010 Total Cost of the process for the review of Abbreviate Applications for Generic New Animal Drugs
Management Challenges for FY2011
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Appendices
- Appendix A: Conditions for Assessment and Use of Fees
Appendix B: Number of Fees Paid in FY2010 Appendix C: Waivers and Reductions Granted - Appendix D: Allowable and Excluded Costs for the process for the review of Abbreviated Applications for Generic New Drug
- Appendix E: Development of Costs for the process for the review of Abbreviated Applications for Generic New Animal Drugs
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