Original BLA and BLA Efficacy Supplement Resubmissions MDUFMA FY 2006
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 two on-time goals in FY 2005 and FY 2006. Both on-time goals ranged from 75 to 80 percent of actions. Final and preliminary performance data indicate FDA is exceeding both on-time goals, with no submissions to act on in FY 2006 for the goal to review and act on Class 1 resubmissions.