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 CDER FIRST ACTION PERFORMANCE FOR RESUBMITTED NDAs
Data as of FY 2005 Close-Out Cohort

CDER


 NO.
SUBMITTED		  

RF
or WF

  

UN

  

NO.
FILED

 NUMBER OF FIRST ACTIONS
WITHIN GOAL		 PDUFA
GOALS		 NUMBER OF FIRST ACTIONS
OVERDUE
          AP AE NA WD TOTAL   AP AE NA WD TOTAL
                  NO. PERCENT           NO. PERCENT
FY93
as of 9/30/96		 2 0 0 2 2 0 0 0 2 100% no goal 0 0 0 0 0 0%
                                 
                                   
FY94
as of 3/31/97		 24 0 0 24 12 5 3 0 20 83% 55% 1 0 3 0 4 17%
                                 
                                   
FY95
as of 3/31/97		 58 0 0 58 36 15 5 0 56 97% 70% 1 1 0 0 2 3%
                                 
                                   
FY96
as of 2/28/98		 89 0 0 89 67 16 5 0 88 99% 80% 0 1 0 0 1 1%
                                 
                                   
FY97
as of 11/30/98		 87 0 0 87 62 17 3 2 84 97% 90% 1 0 2 0 3 3%
                                 
                                   
FY98
as of 01/31/00		 Class 1 22 16 1 1 0 18 82% 30% in 2 mos* 0 0 0 0 0 0%
19 2 1 0 22 100% 90% in 6 mos. 0 0 0 0 0 0%
Class 2 32 19 8 5 0 32 100% 90% 0 0 0 0 0 0%
Total 54 38 10 6 0 54 100% 90% 0 0 0 0 0 0%
                               
FY99
as of 12/31/00		 Class 1 17 14 3 0 0 17 100% 50% in 2 mos.*            
14 3 0 0 17 100% 90% in 4 mos. 0 0 0 0 0 0%
Class 2 47 22 22 3 0 47 100% 90% 0 0 0 0 0 0%
  Total 64                          
                               
FY00
as of 10/31/01		 Class 1 25 22 2 0 0 24 96% 70% in 2 mos.*            
23 2 0 0 25 100% 90% in 4 mos. 0 0 0 0 0 0%
Class 2 55 22 25 6 1 54 98% 90% 1 0 0 0 1 2%
  Total 80                          
                               
FY01
as of 09/30/02		 Class 1 25 18 4 0 0 22 88% 90% in 2 mos. 2 1 0 0 3 12%
Class 2 37 20 12 5 0 37 100% 90% 0 0 0 0 0 0%
  Total 62                          
                               
FY02
as of 02/29/04		 Class 1 20 15 4 1 0 20 100% 90% in 2 mos. 0 0 0 0 0 0%
Class 2 42 28 12 2 0 42 100% 90% in 6 mos. 0 0 0 0 0 0%
  Total 62                          
                               
FY03
as of 10/31/04		 Class 1 24 20 2 1 0 23 96% 90% in 2 mos. 1 0 0 0 1 4%
Class 2 38 23 11 3 1 38 100% 90% in 6 mos. 0 0 0 0 0 0%
  Total 62                          
                               
FY04
as of 8/31/06		 Class 1 21 15 5 1 0 21 100% 90% in 2 mos. 0 0 0 0 0 0%
Class 2 62 40 17 3 1 61 98% 90% in 6 mos. 1 0 0 0 1 2%
  Total 83                          
                               
FY05
as of 10/31/06		 Class 1 21 17 2 0 0 19 90% 90% in 2 mos. 1 1 0 0 2 10%
Class 2 35 20 10 2 0 32 91% 90% in 6 mos. 2 1 0 0 3 9%
  Total 56                          

* The Class 1 Resubmission 2-month goal and performance figures are a subset of the 6- or 4-month goals.  These resubmissions are only considered overdue when they exceed the applicable 6- (FY98) or 4-month goal (FY99 & FY00).

Starting in fiscal year 1998, resubmitted NDAs were characterized as either Class 1 or Class 2 resubmissions.

Abbreviations:

AP             Approved
AE             Approvable
NA            Not approvable
WD            Withdrawn   
RF             Refuse to file
WF            Withdrawn from filing
UN            Unacceptable for filing because user fee not received

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Date created: November 14, 2006; Updated January 17, 2007
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