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Appendix B: Summary of the AGDUFA Performance Goals

FY 2009 AGDUFA Performance Report Table of Contents

The table below summarizes the AGDUFA performance goals for FY 2009 through FY 2013.

Activity Performance level FDA Review Time (Days)
FY 09 FY 10 FY 11 FY 12 FY 13
Original ANADAs and reactivations of such applications
90%
 700 680 500 380 270
Administrative ANADAs
90%
 120 115 110 105 100
Manufacturing supplemental ANADAs and reactivations of such supplemental applications
90%
 600 570 420 340 270
JINAD study submissions
90%
 700 680 500 380 270
JINAD submissions consisting of protocols, that the agency and the sponsor consider to be an essential part of the basis for making the decision to approve or not approve an animal drug application or supplemental animal drug application, without substantial data
90%
 400 390 290 190 100
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