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 CDER FIRST ACTION PERFORMANCE FOR ORIGINAL EFFICACY SUPPLEMENTS
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		 97 4 1 92 14 16 5 3 38 41% no goal 10 18 21 5 54 59%
 
FY94
as of 3/31/97		 106 6 14 86 18 29 14 5 66 77% 55% 10 5 5 0 20 23%
 
FY95
as of 3/31/97		 94 4 13 77 27 34 10 2 73 95% 70% 0 2 2 0 4 5%
 
FY96
as of 2/28/98		 117 3 9 105 60 32 7 4 103 98% 80% 0 2 0 0 2 2%
 
FY97
as of 11/30/98		 P 11 0 1 10 8 1 0 1 10 100% 90% 0 0 0 0 0 0%
S 147 2 9 136 84 20 22 8 134 99% 90% 2 0 0 0 2 1%
Total 158 2 10 146 92 21 22 9 144 99% 90% 2 0 0 0 2 1%
   
FY98
as of 01/31/00		 P 10 0 0 10 8 0 0 0 8 80% 90% 0 0 2 0 2 20%
S 130 5 8 117 69 25 16 6 116 99% 90% 0 1 0 0 1 1%
Total 140 5 8 127 77 25 16 6 124 98% 90% 0 1 2 0 3 2%
   
FY99
as of 12/31/00		 P 15 0 0 15 9 1 2 1 13 87% 90% 0 2 0 0 2 13%
S 138 8 8 122 69 18 13 4 104 85% 30% in 10 mos.*            
76 22 18 6 122 100% 90% in 12 mos. 0 0 0 0 0 0%
Total 153 8 8 137                          
                             
 

FY00
as of 10/31/01

 		 P 18 0 0 18 15 2 0 1 18 100% 90% 0 0 0 0 0 0%
S 178 7 14 157 63 50 22 7 142 90% 50% in 10 mos.*            
68 54 24 10 156 99% 90% in 12 mos. 0 1 0 0 1 1%
Total 196 7 14 175                          
                             
 

FY01
as of 09/30/02

 		 P 7 0 0 7 4 2 0 0 6 86% 90% 0 0 1 0 1 14%
S 158 7 3 147 67 41 13 14 135 92% 70% in 10 mos.*            
77 42 14 14 147 100% 90% in 12 mos. 0 0 0 0 0 0%
Total 164 7 3 154                          
                             
 

FY02
as of 02/29/04

 		 P 31 0 0 31 13 9 6 3 31 100% 90% in  6 mos. 0 0 0 0 0 0%
S 141 4 9 128 66 34 23 3 126 98% 90% in 10 mos.  2 0 0 0 2 2%
Total 172 4 9 159                          
                             
 

FY03
as of 10/31/04

 		 P 35 0 0 35 24 8 3 0 35 100% 90% in  6 mos. 0 0 0 0 0 0%
S 110 2 5 103 50 33 17 0 100 97% 90% in 10 mos. 3 0 0 0 3 3%
Total 145 2 5 138                          
                             
 

FY04
as of 8/31/06

 		 P 52 0 4 48 32 7 3 2 44 92% 90% in  6 mos. 2 1 1 0 4 8%
S 150 3 12 135 71 30 22 6 129 96% 90% in 10 mos. 2 1 3 0 6 4%
Total 202 3 16 183                          
                             
 

FY05
as of 10/31/06

 		 P 35 1 0 34 21 10 3 0 34 100% 90% in  6 mos. 0 0 0 0 0 0%
S 97 1 5 91 65 18 2 3 88 97% 90% in 10 mos. 3 0 0 0 3 3%
Total 132 2 5 125