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PDUFA Workload: FY 2003 through FY 2008

FY 2008 PDUFA Performance Report Table of Contents

Review Workload Levels Uneven in FY 2008. Review workloads for submissions and requests vary each year, and FY 2008 continued that trend (see table below). In FY 2008, the workload for original NDAs and BLAs filed was up 20 percent compared to the average for the previous 5 years, while the review workload for resubmitted NDAs and BLAs and all supplements was down. Review workload planning and review performance can be impacted by workload increases and decreases from one year to the next.

Review Workloads

Submission/Request Fiscal Year FY 2003 to
FY 2007
(5-Year Average)		 FY 2008 Compared to
5-Year Average
2003 2004 2005 2006 2007 2008
Original NDAs and BLAs 109 129 111 124 123 143 119.2 +  20%
Resubmitted NDAs and BLAs 74 85 59 61 73 54 70.4 -  23%
NDA and BLA Efficacy Supplements 153 204 158 190 191 141 179.2 -  21%
Resubmitted Efficacy Supplements 59 58 48 37 46 40 49.6 -  19%
NDA and BLA Manufacturing Supplements 2,598 2,500 2,532 2,647 2,663 2,517 2,588.0 -   3%

 

Administrative Workloads Uneven in FY 2008. Similar to review workloads, administrative workloads also vary from one year to the next (see table below). Responses to clinical holds were up by 49 percent when compared to the 5-year average, while the number of meetings scheduled were down by 12 percent and special protocol assessments were down by 7 percent. While major dispute resolutions were even when compared to the 5-year average, the number in any given year remains difficult to plan for or predict.

Administrative Workloads

Submission/Request Fiscal Year FY 2003 to
FY 2007
(5-Year) Average		 FY 2008 Compared to
5-Year Average
2003 2004 2005 2006 2007 2008
Meetings Scheduled 2,002 2,125 2,230 2,273 2,151 1,903 2,156.2 -  12%
Special Protocol Assessments 293 346 396 406 459 354 380.0 -     7%
Responses To Clinical Holds 136 135 130 145 175 213 144.2 +   48%
Major Dispute Resolutions 20 10 9 9 22 14 14.0 Same

 

Next page: Report on FY 2007 and FY 2008 PDUFA Goals

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