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U.S. Department of Health and Human Services

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FY 2009 AGDUFA Performance Report

Commissioner’s Report

I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2009 Performance Report to Congress for the Animal Generic Drug User Fee Act (AGDUFA). On August 14, 2008, AGDUFA was signed into law. This Act amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first ever generic animal drug user fee program for FY 2009 through FY 2013. AGDUFA follows the Animal Drug User Fee Act (ADUFA) model and is also similar to the Prescription Drug User Fee Act (PDUFA) program.  

It is my pleasure to report that FDA made outstanding progress in the first year of implementing AGDUFA and has met all review time goals for FY 2009. FDA hired additional staff, prepared guidance for the industry and staff, and also addressed over 79 percent of the backlog of abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug (JINAD) submissions.  

FDA is committed to improving the efficiency, quality, and predictability of the new animal generic drug review process. We are dedicated to exploring new approaches and technologies that offer high quality, cost-effective improvements in FDA’s review of new animal generic drug applications and submissions. And, we look forward to continued success and significant improvements in the animal generic drug review process that AGDUFA will make possible in the coming years.  

The report that follows presents FDA’s accomplishments for FY 2009, the first year operating under AGDUFA.

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs


Printable Version of the FY 2009 AGDUFA


Executive Summary


On-Time Review Performance for FY 2009