Goal: Review and Act on Complete Efficacy Supplements to NDAs and BLAs
The table below summarizes the annual review time and performance goals for original efficacy supplements to NDAs and BLAs.
|Efficacy Supplement Type||Review Time Goal||Performance Goal
FY 2008 – FY 2012
|Priority||6 months||90% on time|
The total number of efficacy supplements received in FY 2008 decreased to the lowest level in 5 years (see corresponding graph and table). While the total number of BLA efficacy supplements stayed at the FY 2007 level, the number of priority BLA efficacy supplements increased in FY 2008 to levels seen in FY 2005 and FY 2006.
Efficacy Supplements Filed
(Priority / Standard)
|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.
FY 2007 Submissions
FDA reviewed on time most (41 of 46) priority efficacy supplements and most (126 of 145) standard efficacy supplements submitted in FY 2007 (see table below). However, FDA did not meet the performance goals for priority or standard efficacy supplements.
|Efficacy Supplement Type||Performance Goal||Filed||Performance as of September 30, 2007||Final Performance as of September 30, 2008|
|On Time||Overdue||Percent On Time||On Time||Overdue||Percent On Time|
|Priority||Act on 90 percent within 6 months||46||21||3||88%||41||5||89%|
|Standard||Act on 90 percent within 10 months||145||19||1||95%||126*||19||87%|
*Includes one that was pending due to an amendment extension and subsequently acted on within goal.
FY 2008 Submissions
As of September 30, 2008, performance data was available for over half (21 of 38) of priority efficacy supplements filed in FY 2008, and FDA was exceeding the performance goal (see table below). With 17 priority efficacy submissions pending action and not overdue, FDA has the potential to continue to exceed the performance goal. Performance data was available for less than one-fifth (16 of 103) of standard efficacy supplements filed in FY 2008, and FDA was not meeting the performance goal. However, with 87 standard efficacy submissions pending action and not overdue, FDA has the potential to increase overall performance and exceed the performance goal.
Efficacy Supplement Type
|Performance Goal||Filed||Performance as of September 30, 2008||Highest Potential Performance|
|On Time||Overdue||Percent On Time||Pending On Time||On Time||Percent On Time|
|Priority||Act on 90 percent within 6 months||38||20||1||95%||17||37||97%|
|Standard||Act on 90 percent within 10 months||103||14||2||88%||87||101||98%|
Next page: Resubmitted Efficacy Supplements