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Efficacy Supplements

FY 2008 PDUFA Performance Report Table of Contents

Goal: Review and Act on Complete Efficacy Supplements to NDAs and BLAs

The table below summarizes the annual review time and performance goals for original efficacy supplements to NDAs and BLAs.

Efficacy Supplement Type Review Time Goal Performance Goal
FY 2008 – FY 2012
 Submissions
Priority 6 months 90% on time
Standard 10 months

Workload

The total number of efficacy supplements received in FY 2008 decreased to the lowest level in 5 years (see corresponding graph and table). While the total number of BLA efficacy supplements stayed at the FY 2007 level, the number of priority BLA efficacy supplements increased in FY 2008 to levels seen in FY 2005 and FY 2006.

Efficacy Supplements Filed

Efficacy Supplements Filed
(Priority / Standard)

 

Type FY 04 FY 05 FY 06 FY 07* FY 08
NDAs 183 125 151 165 115
(48/135) (34/91) (36/115) (43/122) (30/85)
BLAs 21 33 39 26 26
(2/19) (7/26) (8/31) (3/23) (8/18)
  PDUFA Total 204 158 190 191 141
(50/154) (41/117) (41/117) (46/145) (38/103)

* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report.

 

Performance

FY 2007 Submissions

FDA reviewed on time most (41 of 46) priority efficacy supplements and most (126 of 145) standard efficacy supplements submitted in FY 2007 (see table below). However, FDA did not meet the performance goals for priority or standard efficacy supplements.

 

Efficacy Supplement Type Performance Goal Filed  Performance as of September 30, 2007 Final Performance as of September 30, 2008
On Time   Overdue Percent On Time On Time Overdue Percent On Time
Priority Act on 90 percent within 6 months 46 21 3 88% 41 5 89%
Standard Act on 90 percent within 10 months 145 19 1 95% 126* 19 87%

*Includes one that was pending due to an amendment extension and subsequently acted on within goal.

 

FY 2008 Submissions

As of September 30, 2008, performance data was available for over half (21 of 38) of priority efficacy supplements filed in FY 2008, and FDA was exceeding the performance goal (see table below). With 17 priority efficacy submissions pending action and not overdue, FDA has the potential to continue to exceed the performance goal. Performance data was available for less than one-fifth (16 of 103) of standard efficacy supplements filed in FY 2008, and FDA was not meeting the performance goal. However, with 87 standard efficacy submissions pending action and not overdue, FDA has the potential to increase overall performance and exceed the performance goal.

 


Efficacy Supplement Type		 Performance Goal Filed Performance as of  September 30, 2008 Highest Potential Performance
On Time    Overdue  Percent On Time Pending On Time On Time Percent On Time
Priority Act on 90 percent within 6 months 38 20 1 95% 17 37 97%
Standard Act on 90 percent within 10 months 103 14 2 88% 87 101 98%

Next page: Resubmitted Efficacy Supplements

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