About FDA
Review Performance At-A-Glance for FY 2006 and FY 2007
The tables provide an overview of FDA performance on all PDUFA submissions presented in detail later in the report. The table includes a column to show the types of submissions provided, a column to list all the goals for those submissions, and a column that includes horizontal bars for FY 2006 and FY 2007 to indicate whether FDA is meeting these goals.
Original and Resubmitted Applications
The table for original and resubmitted applications presents six review performance goals. A scale from 0 to 100 percent is provided with a vertical dashed line shown at 90 percent to mark where the bars must reach to indicate FDA is meeting each performance goal. The table shows that FDA exceeded all six of the performance goals in FY 2006, and is meeting or exceeding all but one of the six performance goals in FY 2007.
Original and Resubmitted Efficacy Supplements
The table for original and resubmitted efficacy supplements presents five review performance goals. A scale from 0 to 100 percent is provided with a vertical dashed line shown for one FY 2006 performance goal at 80 percent and all others at 90 percent to mark where the bars must reach to indicate FDA is meeting each performance goal. The table shows that FDA exceeded all five performance goals in FY 2006, and is meeting or exceeding all but one of the five performance goals in FY 2007.
Manufacturing Supplements
The table for original and resubmitted efficacy supplements presents two review performance goals. A scale from 0 to 100 percent is provided with a vertical dashed line shown at 90 percent to mark where the bars must reach to indicate FDA is meeting each performance goal. The table shows that FDA exceeded both performance goals in FY 2006, and is meeting or exceeding both performance goals in FY 2007.
