User fees/ADUFA/AGDUFA Guidances

ADUFA

• CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions
• CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
• CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFA
• CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction
• CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

AGDUFA

• CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions

Resources

• User Fees