|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
*The
standard efficacy supplement 10-month goal and performance figures were a subset of the 12-month
goal and performance figures. These supplements were only considered overdue when they
exceeded the 12-month goal. |
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
P
- Priority Review - Significant improvement compared to marketed
products, in the treatment, diagnosis, or prevention of a disease.
S - Standard Review - The drug appears to have therapeutic
qualities similar to those of one or more already marketed drugs. |
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Reports
Date created: September 18, 2006; Updated January 17, 2007 |
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