Goal: Review and Act on Resubmitted NDAs and BLAs
The table below summarizes the annual review time and performance goals for resubmitted NDAs and BLAs. A resubmission is a firm’s response to 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 submitted1.
|Resubmitted Application Type||Review Time Goal||Performance Goal
FY 2008 – FY 2012 Submissions
|Class 1||2 months||90% on time|
|Class 2||6 months|
The total number of resubmitted applications in FY 2008 fell to the lowest level in 5 years. This is consistent with the higher level of first cycle approvals. This decrease was not reflected in the number of BLAs which has increased for two straight years (see corresponding graph and table).
(Class 1 / Class 2)
|Type||FY 04||FY 05||FY 06||FY 07*||FY 08|
* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report.
1Class 1 and Class 2 resubmissions are defined in the “Definition of Terms” in Appendix A.
FY 2007 Resubmissions
FDA reviewed on time most (16 of 23) Class 1 resubmissions and almost all (47 of 50) Class 2 resubmissions that were submitted in FY 2007 (see table below). FDA did not meet the performance goal for Class 1 resubmissions, but exceeded the performance goal for Class 2 resubmissions.
|Performance Goal||Received||Performance as of September 30, 2007||Final Performance as of September 30, 2008|
|On Time||Percent On Time||On Time||Overdue||Percent On Time|
|Class 1||Act on 90 percent within 2 months||23||15||5||75%||16||7||70%|
|Class 2||Act on 90 percent within 2 months||50||24||0||100%||47||3||94%|
FY 2008 Resubmissions
As of September 30, 2008, performance data was available for over three-fourths (16 of 20) of Class 1 resubmissions received in FY 2008, and FDA was exceeding the performance goal for Class 1 resubmissions (see table below). With four resubmissions pending action and not overdue, FDA has the potential to continue to exceed the performance goal. Performance data was available for over half (20 of 34) of Class 2 resubmissions received in FY 2008, and FDA was not meeting the performance goal. With 14 Class 2 resubmissions pending and not overdue, FDA has the potential to raise overall performance, but not enough to meet the performance goal.
|Performance Goal||Received||Performance as of
September 30, 2008
|Highest Potential Performance|
|On Time||Percent On Time||Pending On Time||On Time||Percent On Time|
|Class 1||Act on 90 percent within 2 months||20||15||1||94%||4||19||95%|
|Class 2||Act on 90 percent within 6 months||34||15||5||75%||14||29||85%|
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