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A resubmission is a firm's response after an FDA action of "approvable," "not approvable," or "complete response" on an application. The applicable performance goal for a resubmission is determined by the year in which the resubmission itself is received, rather than the year in which the original application was submitted. The definitions of Class 1 and Class 2 resubmissions can be found at the end of Appendix A.
|
Goals |
On-Time Performance by Resubmission Year |
|||||
|---|---|---|---|---|---|---|
|
FY 98 |
FY 99 |
FY 00 |
FY 01 |
FY 02 |
||
| Class 1 |
6 months 4 months 2 months |
90% on time -- 30% |
-- 90% 50% |
-- 90% 70% |
-- -- 90% |
-- -- 90% |
|
Class 2 |
6 months |
90% |
90% |
90% |
90% |
90% |
Workload -- Resubmissions received (Class 1/Class 2):
|
|
FY 98 |
FY 99 |
FY 00 |
FY 01 |
FY 02 |
|---|---|---|---|---|---|
|
of Original NDAs |
50 (19/31) |
63 (17/46) |
80 (25/55) |
62 (25/37) |
62(26/36) |
|
of Original BLAs |
21 (5/16) |
14 (2/12) |
9 (1/8) |
16 (6/10) |
15(2/13) |
|
PDUFA Total |
71 (24/47) |
77 (19/58) |
89 (26/63) |
78 (31/47) |
77(28/49) |
FY 2001 Resubmissions:
Twenty-eight of the 31 Class 1 resubmissions received in FY 2001 were reviewed and acted upon within 2 months, and all 47 of the Class 2 resubmissions were reviewed and acted upon within 6 months. Review performance on both classes of FY 2001 resubmissions met or exceeded the 90 percent on-time PDUFA review goals.
|
FY 01 Resubmissions |
Reviewed and acted upon |
Number on time |
Percent on time |
|
|---|---|---|---|---|
|
Class 1 |
2 months |
31 |
28 |
90 |
|
Class 2 |
6 months |
47 |
47 |
100 |
FY 2002 Submissions:
As of September 30, 2002, 21 FY 2002 Class 1 resubmissions and 27 Class 2 resubmissions had been reviewed and acted upon. All had met their respective review goals. With 7 Class 1 and 22 Class 2 resubmissions still pending and not overdue, it is too early to make a final performance determination, but current on-time performance for both classes of resubmissions exceeds the goals.
|
FY 02 Resubmissions |
Reviewed and acted upon |
Number on time |
Percent on time |
|
|---|---|---|---|---|
|
Class 1 |
2 months |
21 |
21 |
100 |
|
Class 2 |
6 months |
27 |
27 |
100 |
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Web page created by cm 2003-MAR-15.