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FY 2013 AGDUFA Performance Report

Commissioner’s Report

 

I am pleased to present the Food and Drug Administration’s (FDA) fiscal year (FY) 2013 Performance report to Congress for the Animal Generic Drug User Fee Act (AGDUFA). On August 14, 2008, AGDUFA was signed into law. AGDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first generic animal drug user fee program from FY 2009 through FY 2013. AGDUFA follows the Animal Drug User Fee Act (ADUFA) model.
 
This report marks the fifth year of FDA performance review under AGDUFA and finalizes performance results for FY 2012, the fourth year of AGDUFA. This report also presents FDA’s preliminary accomplishments for FY 2013. It is my pleasure to report that FDA exceeded all performance goals for FY 2012.  FDA also exceeded review-time goals for all FY 2012 cohort submissions reviewed or due for review by September 30, 2013. FDA is on track to exceed all performance goals for FY 2013.
                                                
Each year under AGDUFA, the number of days to meet the review-time goals is decreased while the overall performance goal level of 90 percent of reviews being compliant with those goals is maintained. FDA agreed to these increasingly challenging goals as part of its commitment to improve the efficiency, quality, and predictability of the generic new animal drug review process.  Under AGDUFA, FDA completely eliminated a backlog of 680 submissions in 22 months. In addition, the Agency has been able to dramatically reduce review times from 700 days to 270 days. 
 
The report that follows presents FDA’s accomplishments for FY 2013, the fifth and final year operating under the original authorizing statute (AGDUFA I). In June 2013, AGDUFA was reauthorized for an additional 5-year period from FY 2014 through FY 2018 (AGDUFA II). The timely approval of generic new animal drugs continues to be a critical component of animal health because it provides quicker access to additional sources of animal drugs at a lower cost for ranchers, farmers, and pet owners.  We look forward to the improvements in the generic new animal drug review process that the AGDUFA program will make possible in the coming years.
 
 
 
 
                        Margaret A. Hamburg, M.D.
                        Commissioner of Food and Drugs
 
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Printable Version of the FY 2013 AGDUFA Performance Report

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