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For Industry
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Resources for You
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Animal Drug User Fee Act (ADUFA)
The Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. These additional resources support FDA’s responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.
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CVM Updates and FDA News Releases
- Sep 15, 2008 FDA Announces FY 2009 Animal Generic Drug User Fee Rates
- Aug 18, 2008 President Bush Signs Reauthorization of User Fees for Pioneer Animal Drugs and Authorization of the First Ever User Fee Program for Generic Animal Drugs
- Apr 25, 2008 FDA Proposes Reauthorization of User Fees for Pioneer Drugs and Authorization of the First-Ever User Fees for Generic Drugs
- Apr 24, 2008 FDA Proposes Recommendations for Two Animal Drug Funding Programs
- Feb 21, 2008 FDA Announces Public Meeting and Comment Period for ADUFA Reauthorization
- Aug 03, 2007 FDA Announces FY 2008 Animal Drug User Fee Rates
- Mar 13, 2007 CVM Public Meeting April 24, 2007: Animal Drug User Fee Act (ADUFA)
- Aug 17, 2006 Draft Guidance on Waivers and Reductions for Animal Drug User Fees Available
- Aug 02, 2006 FDA Announces FY 2007 Animal Drug User Fee Rates
- Aug 01, 2005 FDA Announces FY 2006 Animal Drug User Fee Rates
- Mar 17, 2005 FY 2004 Performance Report to Congress for ADUFA Available
- Sep 28, 2004 Draft Guidance Available on Sponsor Fees Under ADUFA
- Aug 02, 2004 FDA Announces FY 2005 Animal Drug User Fee Rates
- Mar 16, 2004 ADUFA Cover Sheet and Guidance Available
- Feb 18, 2004 FDA Announces Animal Drug User Fee Rates for FY04
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Federal Register Notices
- Notice: Correction; Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010 (August 18, 2009)
- Notice: Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010 (August 3, 2009)
- Notice: Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions; Availability
- Notice: Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2007
- Notice: Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2006
- Notice: Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005
- Notice: Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures
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