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Original Applications

FY 2008 PDUFA Performance Report Table of Contents

Goal: Review and Act on Original NDAs and BLAs

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

Original  Application 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 original applications (PDUFA Total) has increased two of the past 3 years and in FY 2008 reached the highest level in the past 5 years. Most of the increase was with standard applications filed which have now increased for three straight years. The number of BLAs filed increased for the third straight year, as well (see corresponding graph and table).

Original Applications Filed

Original Applications Filed
(Priority/Standard)

Type FY 04 FY 05 FY 06 FY 07* FY 08
NDAs 120 102 112 108 125
(26/94) (29/73) (25/87) (23/85) (26/99)
BLAs 9 9 12 15 18
(3/6) (6/3) (7/5) (7/8) (6/12)
  PDUFA Total 129 111 124 123 143
(29/100) (35/76) (32/92) (30/93) (32/111)
NMEs† 29 30 24 29 30
(16/13) (15/15) (8/16) (9/20) (10/20)

* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report. 
† FDA often receives multiple submissions for the same NME, which are all initially designated as NMEs. When FDA approves the first of the multiple submissions, the others are redesignated as non-NMEs.

 

Performance


FY 2007 Submissions

FDA reviewed on time almost all (28 of 30) priority applications and most (83 of 93) standard applications that were filed in FY 2007 (see table below). FDA exceeded the performance goals for priority applications, but did not meet the performance goals for standard applications.

 

Original Application Type Performance Goal Filed Preliminary 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 All Act on 90 percent within 6 months 30 14 0 100% 28 2 93%
NMEs & BLAs 16 9 0 100% 15 1 94%
Standard All Act on 90 percent within 10 months 93 14 0 100% 83* 10 89%
NMEs & BLAs 28 5 0 100% 24 4 86%

*Includes four that were pending due to amendment extensions and subsequently acted on within goal.

 

FY 2008 Submissions

As of September 30, 2008, performance data was available for over half (17 of 32) of priority applications filed in FY 2008, and FDA was not meeting the performance goals (see table below). With 15 priority applications pending and not overdue, including 6 NMEs and BLAs, FDA has the potential to increase performance, but not enough to meet the performance goals for priority applications. Performance data was available for less than one-fifth (20 of 111) of standard applications filed in FY 2008, and FDA was exceeding the performance goal level for standard applications. With 91 standard applications pending and not overdue, including 21 NMEs and BLAs, FDA has the potential to continue to exceed the performance goals.

 

Original Application 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 All Act on 90 percent within 6 months 32 12 5 71% 15 27 84%
NMEs & BLAs 16 6 4 60% 6 12 75%
Standard All Act on 90 percent within 10 months 111 20 0 100% 91 111 100%
NMEs & BLAs 32 10 1 91% 21 31 97%


Next page: Resubmitted Applications

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