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U.S. Department of Health and Human Services

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Original BLA and BLA efficacy supplement resubmissions MDUFMA FY 2005

The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to original BLA and BLA efficacy supplement resubmissions. Performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of on-time goals in FY 2005. Final performance results are presented for the FY 2005 FDA goal to “Review and act on Class 1 resubmissions” 75 percent on time with FDA exceeding the goal, and preliminary performance data are presented for the FDA goal to “Review and act on Class 2 resubmissions” with FDA exceeding the goal.




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