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U.S. Department of Health and Human Services

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Original PMAs, Panel-track PMA Supplements, and Premarket Reports MDUFMA FY 2005

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 on-time goals in FY 2005. Preliminary data shows that FDA is meeting or exceeding the performance level that is set for these goals prior to and during FY 2005. The one exception relates to an FDA “on-time” goal of 90 percent to “Act on an amendment containing a complete response to an approvable letter.” This goal was initiated in FY 2003. Preliminary performance results show FDA not meeting this goal in FYs 2003 and 2004 and no submissions to act on in FY 2005.



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