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Resubmitted Efficacy Supplements

FY 2008 PDUFA Performance Report Table of Contents

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

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

 

Resubmitted Efficacy
Supplement Type		 Review Time
 Goal		 Performance Goal
FY 2008 – FY 2012
 Submissions
Class 1 2 months 90% on time
Class 2 6 months

 

Workload

After a decrease in FY 2006, the level of NDA resubmitted efficacy supplements has averaged 31 over the past 3 years (FY 2006 to FY 2008). The level of BLA resubmitted efficacy supplements has averaged 10 per year during the same period (see corresponding graph and table).

 

Resubmitted Efficacy Supplements

Resubmitted Efficacy Supplements
(Class 1 / Class 2)

Type FY 04 FY 05 FY 06 FY 07* FY 08
NDAs 55
(32/23)		 44
(23/21)		 29
(13/16)		 34
(16/18)		 30
(12/18)
BLAs 3
(3/0)		 4
(1/3)		 8
(1/7)		 12
(1/11)		 10
(3/7)
PDUFA Total 58
(35/23)		 48
(24/24)		 37
(14/23)		 46
(17/29)		 40
(15/25)
* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report.

 

Performance

FY 2007 Resubmissions

FDA reviewed on time most (14 of 17) Class 1 and almost all (27 of 29) Class 2 efficacy supplement resubmissions submitted in FY 2007 (see table below). FDA did not meet the performance goal for Class 1 resubmissions, but exceeded the performance goal for Class 2 resubmissions.

Resubmitted Efficacy Supplement Type Performance Goal Received  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
Class 1 Act on 90 percent within 2 months 17 14 1 93% 14 3 82%
Class 2 Act on 90 percent within 6 months 29 17 0 100% 27 2 93%


FY 2008 Resubmissions

As of September 30, 2008, performance data was available for over half (9 of 15) of Class 1 resubmitted efficacy supplements submitted in FY 2008, and FDA was exceeding the performance goal (see table below). With 6 Class 1 resubmitted efficacy supplements pending action and not overdue, FDA has the potential to continue to exceed the performance goal. Performance data was available for over half (14 of 25) of Class 2 resubmitted efficacy supplements submitted in FY 2008, and FDA was exceeding the performance goal. With 11 Class 2 resubmitted efficacy submissions pending and not overdue, FDA has the potential to continue to exceed the performance goal.


Resubmitted Efficacy Supplement Type		 Performance Goal Received Performance as of  September 30, 2008 Highest Potential Performance
On Time    Overdue  Percent On Time Pending On Time On Time Percent On Time
Class 1 Act on 90 percent within 2 months 15 9 0 100% 6 15 100%
Class 2 Act on 90 percent within 6 months 25 13 1 93% 11 24 96%

Next page: Manufacturing Supplements

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