![[Skip navigation]](https://webarchive.library.unt.edu/eot2008/20090120134120im_/http://www.fda.gov/graphics/miscellaneous/dot_clear.gif){kind=small}
The table below summarizes the annually decreasing review-time goals for original New Drug Applications (NDAs) and BLAs under PDUFA II. Over the five-year period, the goal of reviewing 90 percent of priority applications in six months remained constant. For standard applications, the review-time goals dropped over the five-year period. For applications filed in FY 1998, the goal was to review 90 percent in 12 months; for FY 2002 applications, the goal is to review 90 percent in 10 months. The statute allows three additional months for review of original NDA and BLA submissions that involve major amendments received within the last three months of their usual review intervals.
|
Goals |
On-Time Performance by Submission Year |
|||||
|---|---|---|---|---|---|---|
|
FY 98 |
FY 99 |
FY 00 |
FY 01 |
FY 02 |
||
|
Priority |
6 months |
90% on time |
90% |
90% |
90% |
90% |
|
Standard |
12 months 10 months |
90% NA |
90% 30% |
90% 50% |
90% 70% |
NA 90% |
The following table shows the number of original NDAs and BLAs filed in each of the last five years. The count of FY 2002 submissions assumes that all submissions received in the last two months of FY 2002 are filed. When FDA files a submission, it is deemed "complete" by PDUFA definition. FDA makes a filing decision within 60 days of an original application's receipt. All calculations of PDUFA review times are made, however, from the original receipt date of the filed application.
Original submissions filed (Priority/Standard):
|
FY 98 |
FY 99 |
FY 00 |
FY 01 |
FY 024 |
|
|---|---|---|---|---|---|
|
109 (30/79) |
121 (30/91) |
121 (29/92) |
96 (10/86) |
100(9/91) |
|
12 (8/4) |
6 (1/5) |
13 (4/9) |
8 (3/5) |
9 (3/6) |
|
121 (38/83) |
127 (31/96) |
134 (33/101) |
104 (13/91) |
109(12/97) |
|
NMEs5 |
42 (19/23) |
41 (16/25) |
32 (17/15) |
34 (8/26) |
23(7/16) |
FDA met the goal of reviewing and acting upon priority applications within 6 months for all thirteen priority NDAs and BLAs filed in FY 2001. FDA also met the 12-month goal for standard submissions for 89 of the 91 standard submissions reviewed (98% on time). Ninety percent of all standard applications and 81 percent of the NMEs and BLAs were reviewed and acted upon within 10 months, exceeding the 70 percent review goal in both cases.
FY 01 Submissions
|
|
Reviewed and acted upon |
Number on time |
Percent on time |
||
|---|---|---|---|---|---|
|
Priority |
6 month goal |
All Applications |
13 |
13 |
100 |
|
NMEs & BLAs |
11 |
11 |
100 |
||
|
Standard |
12 month goal |
All Applications |
91 |
89 |
98* |
|
NMEs & BLAs |
31 |
29 |
94* |
||
|
10 month goal |
All Applications |
91 |
82 |
90 |
|
|
NMEs & BLAs |
31 |
25 |
81 |
||
* Because receipt of a major amendment extended the 10-month goal to 13 months, the two standard applications(both NMEs) that did not meet the 12-month goal met the extended 10-month goal.
FY 2002 Submissions
While it is too early to report meaningful review performance statistics for applications submitted in FY 2002, all priority applications that have been reviewed have met the 6-month review goal, and all standard applications that have been reviewed have met the 10-month review goal. No applications are late.
FY 02 Submissions
|
|
Reviewed and acted upon |
Number on time |
Percent on time |
||
|---|---|---|---|---|---|
|
Priority |
6 month goal |
All Applications |
4 |
4 |
100 |
|
NMEs & BLAs |
4 |
4 |
100 |
||
|
Priority |
10 month goal |
All Applications |
16 |
16 |
100 |
|
NMEs & BLAs |
7 |
7 |
100 |
||
FDA Home Page | Search | A-Z
Index | Site Map | Contact FDA
FDA/Office of Planning
Web page created by cm 2003-MAR-15.