CDER FIRST
ACTION PERFORMANCE FOR ORIGINAL MANUFACTURING 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 |
1059 |
14 |
0 |
1045 |
450 |
22 |
44 |
10 |
526 |
50% |
no
goal |
287 |
21 |
194 |
17 |
519 |
50% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY94
as of 3/31/97 |
884 |
11 |
2 |
871 |
391 |
39 |
137 |
5 |
572 |
66% |
55% |
248 |
12 |
34 |
5 |
299 |
34% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY95
as of 3/31/97 |
1285 |
34 |
2 |
1249 |
752 |
60 |
271 |
38 |
1121 |
90% |
70% |
83 |
7 |
34 |
4 |
128 |
10% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY96
as of 2/28/98 |
1238 |
20 |
0 |
1218 |
991 |
60 |
87 |
32 |
1170 |
96% |
80% |
27 |
5 |
16 |
0 |
48 |
4% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY97
as of 11/30/98 |
1267 |
5 |
0 |
1262 |
1034 |
126 |
72 |
9 |
1241 |
98% |
90% |
14 |
2 |
3 |
2 |
21 |
2% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY98
as of 01/31/00 |
1477 |
11 |
3 |
1463 |
1235 |
76 |
108 |
23 |
1442 |
99% |
90% |
19 |
1 |
1 |
0 |
21 |
1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY99
as of 12/31/00 |
Prior Approval |
913 |
10 |
1 |
902 |
536 |
70 |
45 |
9 |
660 |
73% |
30% in 4 mos.* |
|
|
|
|
|
694 |
107 |
72 |
16 |
889 |
99% |
90% in 6 mos. |
8 |
2 |
3 |
0 |
13 |
1% |
CBE |
567 |
10 |
0 |
557 |
494 |
36 |
13 |
4 |
547 |
98% |
90% |
7 |
1 |
2 |
0 |
10 |
2% |
|
Total |
1480 |
20 |
1 |
1459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY00
as of 10/31/01 |
Prior Approval |
700 |
11 |
5 |
684 |
401 |
64 |
31 |
13 |
509 |
74% |
50% in 4 mos.* |
|
|
|
|
|
517 |
86 |
44 |
15 |
662 |
97% |
90% in 6 mos. |
11 |
7 |
4 |
0 |
22 |
3% |
CBE |
766 |
12 |
0 |
754 |
685 |
28 |
18 |
7 |
738 |
98% |
90% |
14 |
2 |
0 |
0 |
16 |
2% |
|
Total |
1466 |
23 |
5 |
1438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY01
as of 09/30/02 |
Prior Approval |
589 |
9 |
1 |
579 |
364 |
69 |
39 |
10 |
482 |
83% |
70% in 4 mos.* |
|
|
|
|
|
429 |
78 |
49 |
11 |
567 |
98% |
90% in 6 mos. |
6 |
4 |
2 |
0 |
12 |
2% |
CBE |
913 |
9 |
9 |
895 |
825 |
30 |
13 |
12 |
880 |
98% |
90% |
13 |
2 |
0 |
0 |
15 |
2% |
|
Total |
1502 |
18 |
10 |
1474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY02
as of 02/29/04 |
Prior Approval |
618 |
9 |
7 |
602 |
431 |
90 |
37 |
5 |
563 |
94% |
90% in 4 mos. |
21 |
15 |
2 |
1 |
39 |
6% |
CBE |
1212 |
50 |
5 |
1157 |
1012 |
93 |
10 |
8 |
1123 |
97% |
90% in 6 mos. |
33 |
1 |
0 |
0 |
34 |
3% |
|
Total |
1830 |
59 |
12 |
1759 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY03
as of 10/31/04 |
Prior Approval |
624 |
7 |
0 |
617 |
436 |
122 |
37 |
5 |
600 |
97% |
90% in 4 mos. |
12 |
4 |
1 |
0 |
17 |
3% |
CBE |
1101 |
20 |
2 |
1079 |
993 |
50 |
6 |
14 |
1063 |
99% |
90% in 6 mos. |
12 |
4 |
0 |
0 |
16 |
1% |
|
Total |
1725 |
27 |
2 |
1696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY04
as of 8/31/06 |
Prior Approval |
535 |
5 |
6 |
524 |
387 |
76 |
23 |
5 |
491 |
94% |
90% in 4 mos. |
25 |
7 |
0 |
1 |
33 |
6% |
CBE |
1108 |
9 |
6 |
1093 |
1023 |
33 |
7 |
9 |
1072 |
98% |
90% in 6 mos. |
16 |
4 |
0 |
1 |
21 |
2% |
|
Total |
1643 |
14 |
12 |
1617 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY05
as of 10/31/06 |
Prior Approval |
636 |
5 |
1 |
630 |
508 |
77 |
18 |
9 |
612 |
97% |
90% in 4 mos. |
16 |
2 |
0 |
0 |
18 |
3% |
CBE |
1085 |
16 |
4 |
1065 |
1000 |
38 |
4 |
8 |
1050 |
99% |
90% in 6 mos. |
15 |
0 |
0 |
0 |
15 |
1% |
|
Total |
1721 |
21 |
5 |
1695 |
|
|
|
|
|
|
|
|
|
|
|
|
*The Prior
Approval 4-month goal and performance figures are a subset of the 6-month goal
and performance figures. These supplements are only considered overdue when they exceed
the 6-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
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Reports
Date created: November 14, 2006; Updated January 17, 2007 |