Expedited PMAs MDUFMA FY 2006
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to Expedited PMAs. With one exception, performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of five on-time goals in FYs 2005 and 2006. On-time goals range from 70 to 90 percent of actions. Final FDA performance data indicated FDA met or exceeded all on-time goals with one reported in FY 2003 and two reported in FY 2005. Preliminary performance data indicated that FDA is meeting or exceeding, with two exceptions, the performance level that is set for these goals prior to and during FYs 2005 and 2006. One exception relates to an FDA on-time goal in FY 2005 to make an FDA decision where the preliminary performance result was slightly below 70 percent. The other exception relates to an FDA on-time goal during FY 2004 to act on an amendment containing a complete response to an approvable letter where the preliminary performance results were below the 90 percent goal.