Original PMAs, Panel-track PMA Supplements, and Premarket Reports MDUFMA FY 2006
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to original PMAs, Panel-track PMA Supplements, and Premarket Reports. With one exception, performance data 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 75 to 90 percent of actions. Preliminary data shows 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 issue a major deficiency letter as the second or later action where the preliminary performance result was slightly below the 75 percent goal. The other exception relates to an FDA on-time goal during FYs 2003 and 2005 to act on an amendment containing a complete response to an approvable letter where the preliminary performance results were below the 90 percent goal.