Goal: Review and Act on Manufacturing Supplements to NDAs and BLAs
The table below summarizes the annual review time and performance goals for NDA and BLA manufacturing supplements.
|Manufacturing Supplement Type||Review Time
FY 2008 – FY 2012
|Prior Approval Required||4 months||90% on time|
|Prior Approval Not Required||6 months|
Total manufacturing supplements filed increased in FY 2005, FY 2006 and FY 2007, then decreased by 5 percent in FY 2008, returning to levels similar to FY 2004 and FY 2005. Most of the decrease was with NDA manufacturing supplements. While BLA supplements not requiring prior approval decreased (by 5 percent), the number of BLA supplements filed requiring prior approval increased by 38 percent in FY 2008, as compared to FY 2007, to the highest level for this category in 5 years (see corresponding graph and table).
Manufacturing Supplements Filed
(Prior Approval / No Prior Approval)
|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 almost all (2,570 of 2,663) manufacturing supplements received in FY 2007 (see table below). FDA exceeded the performance goals for manufacturing supplements where prior approval was required and where prior approval was not required.
|Manufacturing Supplement Type||Performance Goal||Received||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|
|Prior Approval Required||Act on 90 percent within 4 months||854||541||24||96%||797||57||93%|
|Prior Approval Not Required||Act on 90 percent within 6 months||1,809||966||6||99%||1,773||36||98%|
FY 2008 Submissions
As of September 30, 2008, performance data was available for two-thirds (608 of 906) of manufacturing supplements received in FY 2008 requiring prior approval, and FDA was not meeting the performance goal (see table below). However, with 298 supplements pending and not overdue, FDA has the potential to increase overall performance and exceed the performance goal. Performance data was available for just over half (863 of 1,611) of supplements not requiring prior approval received in FY 2008, and FDA was exceeding the performance goal. With 748 supplements pending action and not overdue, FDA has the potential to continue to exceed the performance goal.
Manufacturing Supplement Type
|Performance Goal||Received||Performance as of September 30, 2008||Highest Potential Performance|
|On Time||Overdue||Percent On Time||Pending On Time||On Time||Percent On Time|
|Prior Approval Required||Act on 90 percent within 4 months||906||537||71||88%||298||835||92%|
|Prior Approval Not Required||Act on 90 percent within 6 months||1,611||814||49||94%||748||1,562||97%|