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% |
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|
|
FY94
as of 3/31/97 |
24 |
0 |
0 |
24 |
12 |
5 |
3 |
0 |
20 |
83% |
55% |
1 |
0 |
3 |
0 |
4 |
17% |
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|
FY95
as of 3/31/97 |
58 |
0 |
0 |
58 |
36 |
15 |
5 |
0 |
56 |
97% |
70% |
1 |
1 |
0 |
0 |
2 |
3% |
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|
FY96
as of 2/28/98 |
89 |
0 |
0 |
89 |
67 |
16 |
5 |
0 |
88 |
99% |
80% |
0 |
1 |
0 |
0 |
1 |
1% |
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|
FY97
as of 11/30/98 |
87 |
0 |
0 |
87 |
62 |
17 |
3 |
2 |
84 |
97% |
90% |
1 |
0 |
2 |
0 |
3 |
3% |
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|
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% |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
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 |
|
|
|
|
|
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|
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 |
|
|
|
|
|
|
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|
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|
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 |
|
|
|
|
|
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|
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 |
|
|
|
|
|
|
|
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|
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 |
|
|
|
|
|
|
|
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|
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 |
|
|
|
|
|
|
|
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|
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 |
|
|
|
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* 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
Back to Top
Reports
Date created: November 14, 2006; Updated January 17, 2007 |