|
CDER FIRST
ACTION PERFORMANCE FOR RESUBMITTED EFFICACY SUPPLEMENTS
Data as of
FY 2005 Close-Out Cohort
CDER
|
FISCAL
YEAR |
TYPE |
NO.
SUBMITTED |
PDUFA
GOALS |
NUMBER
OF FIRST ACTIONS WITHIN GOAL |
NUMBER
OF FIRST ACTIONS OVERDUE |
|
|
|
|
AP |
AE |
NA |
WD |
TOTAL |
AP |
AE |
NA |
WD |
TOTAL |
|
|
|
|
|
|
|
|
NO. |
PERCENT |
|
|
|
|
NO. |
PERCENT |
|
FY
03 as of 10/31/04 |
Class
1 |
16 |
30%
in 2 mos. |
12 |
3 |
0 |
0 |
15 |
94% |
|
|
|
|
|
|
|
90%
in 6 mos. (cum.) |
12 |
3 |
1 |
0 |
16 |
100% |
0 |
0 |
0 |
0 |
0 |
0% |
|
Class
2 |
40 |
90%
in 6 mos. |
31 |
8 |
1 |
0 |
40 |
100% |
0 |
0 |
0 |
0 |
0 |
0% |
|
Total |
56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY
04 as of 8/31/06 |
Class
1 |
32 |
50%
in 2 mos. |
29 |
0 |
1 |
0 |
30 |
94% |
|
|
|
|
|
|
|
90%
in 6 mos. (cum.) |
30 |
1 |
1 |
0 |
32 |
100% |
0 |
0 |
0 |
0 |
0 |
0% |
|
Class
2 |
23 |
90%
in 6 mos. |
11 |
6 |
5 |
0 |
22 |
96% |
1 |
0 |
0 |
0 |
1 |
4% |
|
Total |
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY
05 as of 10/31/06 |
Class
1 |
23 |
70%
in 2 mos. |
19 |
2 |
2 |
0 |
23 |
100% |
|
|
|
|
|
|
|
90%
in 6 mos. (cum.) |
19 |
2 |
2 |
0 |
23 |
100% |
0 |
0 |
0 |
0 |
0 |
0% |
|
Class
2 |
21 |
90%
in 6 mos. |
7 |
4 |
5 |
4 |
20 |
95% |
1 |
0 |
0 |
0 |
1 |
5% |
|
Total |
44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
* The Class 1 Resubmission 2-month goal and performance
figures are a subset of the 6-month goal. These
resubmissions are only considered overdue when they exceed the applicable
6-month goal.
Abbreviations:
|
AP
Approved
|
|
AE
Approvable
|
|
NA
Not approvable
|
|
WD Withdrawn
|
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Reports
Date created: November 14, 2006; Updated January 17, 2007 |
