Report on PDUFA Goals: Efficacy Supplements

Goal -- Review and act upon complete efficacy supplements to NDAs and BLAs

The table below summarizes the annually decreasing review-time goals for efficacy supplements to NDAs and BLAs under PDUFA II. Review goals for efficacy supplements follow the same progression as the review goals for original NDAs and BLAs. Over the five-year period, the goal of reviewing 90 percent of priority efficacy supplements in six months remained constant. For standard efficacy supplements, the review-time goals dropped over the five-year period. For FY 1998 submissions, the goal was to review 90 percent in 12 months; for FY 2002 submissions, the goal was to review 90 percent in 10 months.

Goals

Workload

Workload -- Efficacy supplements filed (Priority / Standard):

Performance

FY 2001 Submissions

Eight of the 9 priority efficacy supplements submitted in FY 2001 were reviewed and acted upon within the 6-month review goal. On-time performance was 89 percent, which is slightly below the 90 percent goal.

All of the standard efficacy supplements were reviewed and acted upon within 12 months and 91 percent were reviewed within 10 months. This performance exceeds the FY 2001 goals of 90 percent and 70 percent respectively.

FY 01 Submissions

FY 2002 Submissions

While it is too early to report meaningful review performance statistics for efficacy supplements submitted in FY 2002, all priority efficacy supplements that have been reviewed have met the 6-month review goal and all standard efficacy supplements that have been reviewed have met the 10-month review goal. No efficacy supplements are late.

FY 02 Submissions

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