The review performance goals for manufacturing supplements that do not require FDA approval before the changes they specify can be enacted do not change over the five years of PDUFA ii. For manufacturing supplements that do require FDA's approval, the goal times decrease from 6 months for FY 98 submissions to 4 months for FY 02 submissions.
Goals |
On-Time Performance by Submission Year |
|||||
---|---|---|---|---|---|---|
FY 98 |
FY 99 |
FY 00 |
FY 01 |
FY 02 |
||
Prior approval not required |
6 months |
90% on time |
90% |
90% |
90% |
90% |
Prior approval required |
6 months 4 months |
90% |
90% 30% |
90% 50% |
90% 70% |
90% |
Workload -- Manufacturing supplements filed (Total / Prior Approval Required): |
|||||
---|---|---|---|---|---|
FY 96 |
FY 97 |
FY 98 |
FY 99 |
FY 00 4 |
|
to NDAs |
1,218 |
1,262 |
1,463 |
1,459 (900) |
1,446 (708) |
to BLAs |
261 |
338 |
371 |
477 (259) |
569 (244) |
PDUFA total |
1,479 |
1,600 |
1,834 |
1,936 (1,159) |
2,015 (952) |
FY 99 Submissions:
Ninety-eight percent of the manufacturing supplements that did not require prior FDA approval submitted in FY 99 were reviewed within 6 months. That level of performance exceeded the 90 percent on-time review goal.
Ninety-eight percent of the manufacturing supplements that required prior FDA approval submitted in FY 99 also were reviewed within 6 months. Seventy-six percent of these were reviewed within 4 months. That level of performance exceeded FY 99's goals of 90 percent and 30 percent respectively.
FY 99 Submissions |
Reviewed and acted upon |
Number on time |
Percent on time |
|
---|---|---|---|---|
Prior approval not required |
6 months |
777 |
759 |
98 |
Prior approval required |
6 months 4 months |
1159 |
1141 887 |
98 76 |
FY 00 Submissions:
As of September 30, 2000, almost 59 percent of the manufacturing supplements that do not require prior approval, and 64 percent of those that do require prior approval had been reviewed. Ninety-nine percent of both categories of manufacturing supplements had been reviewed within 6 months, and 82 percent of those requiring prior approval had been reviewed within 4 months. Although it is too early to make a final determination with only 61 percent of the submissions reviewed, performance in all categories is well above the FY 00 review goals.
FY 00 Submissions |
Reviewed and acted upon |
Number on time |
Percent on time |
|
---|---|---|---|---|
Prior approval not required |
6 months |
625 |
620 |
99 |
Prior approval required |
6 months 4 months |
610 |
605 503 |
99 82 |
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Web page created by cm 2001-MAR-01.