PDUFA III Management Initiatives Performance for FY 2004 and FY 2005
The horizontal bar graph provides actual and preliminary “on-time” performance related to first cycle filing review notifications for original NDAs, BLAs, and efficacy supplements and reviewable unit letter notifications for NDAs and BLAs. On-time goals range from 30 to 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 for first cycle filing review notifications of efficacy supplements where preliminary FDA performance was slightly below the 90 percent goal.