Review Performance At-A-Glance for FY 2004 and FY 2005 Original and Resubmitted Applications
The horizontal bar graph provides FDA actual and preliminary “on-time” performance on six actions related to original and resubmitted NDA and BLA applications. All on-time goals are at 90 percent of actions. Performance results for FY 2004 and preliminary performance results for FY 2005 show that, with one exception, FDA is meeting or exceeding the performance levels that were set for each of these goals. The one exception relates to an FDA on-time goal during FY 2005 to review and act on Class 2 resubmitted applications where preliminary FDA performance was slightly below the 90 percent goal.