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Maintenance of Current Performance

FY 2009 MDUFA Performance Report Table of Contents

The table below presents FDA’s review performance for submissions over the last 5 years that do not have explicit MDUFA II performance goals. FDA’s performance in FY 2009 continued to be comparable to performance during the previous 4 years, with the exception of FY 2008 135-day PMA supplements. FDA’s performance for 135-day PMA supplements in FY 2009 returned to performance levels comparable to FY 2005 through FY 2007, after performance fell below these levels in FY 2008.

Performance Indicators

FY 05

FY 06

FY 07

FY 08

FY 09

BLA Supplements (CBE/CBE-30) -  Percent reviewed and acted on within 6 months 100%  99%* 100% 100% 100%
IDEs - Percent of decisions made within 30 days 96% 99% 99% 99% 99%
IDE Amendments - Percent of decisions made within 30 days 98% 100% 98% 98% 99%*
IDE Supplements - Percent of decisions made within 30 days 100% 100% 99% 100% 99%*
PMA Supplements (CBE) - Percent of decisions made within 180 days 100% 100% 100% 100% 100%
PMA Supplements (135 day) - Percent of decisions made within 135 days 100% 100% 100% 86% 100%
PMA Supplements (CBE-30) - Percent of decisions made within 30 days 100% 100% 100% 100% 100%

* Percentages above 99 percent, but below 100 percent, are rounded down to 99 percent.
KEY: IDEs-Investigational Device Exemptions; BLA-Biologic License Application; PMA-Premarket Approval Application; CBE-Changes Being Effected
NOTE: Some reported measures may change over time, as additional actions are taken on open applications.


Biologics Applications Review Performance for FY 2008 and FY 2009

MDUFA II does not provide explicit performance goals for biologics applications; however, FDA continues to report on performance for biologics applications using performance goals defined under MDUFMA I. This approach is part of FDA’s general commitment to maintain and report on performance on review workloads not covered by MDUFA II performance goals.


Performance for FY 2008

The table below updates FDA’s final performance for reviewing and acting on biologics applications in FY 2008. FDA reviewed on time 100 percent (15 of 15) of filed standard BLAs, 100 percent (227 of 227) of submitted BLA manufacturing supplements, 98 percent (100 of 102) of resubmitted “Class 1” BLAs and BLA efficacy supplements, and 100 percent (2 of 2) of resubmitted “Class 2” BLAs and BLA efficacy supplements in FY 2008 (see table below). As a result, FDA exceeded all performance goals for BLAs, BLA supplements, and resubmitted BLAs and BLA efficacy supplements for FY 2008 in areas where submissions were received.

BLAs

Goals MDUFMA I Performance Goals Cohort Closed Received Final Performance
Overdue On Time Percent
On Time
Review and act on priority original BLAs Act on 90% within 6 months Y 0 -- -- --
Review and act on standard original BLAs Act on 90% within 10 months Y 15* 0 15 100%

BLA SUPPLEMENTS

Goals MDUFMA I Performance Goals Cohort Closed Received Final Performance
Overdue On Time Percent
On Time
Review and act on BLA manufacturing supplements that require prior approval Act on 90% within 4 months Y 227* 0 227 100%
Review and act on priority BLA efficacy supplements Act on 90% within 6 months Y 0 -- -- --
Review and act on standard BLA efficacy supplements Act on 90% within 10 months Y 0 -- -- --

RESUBMITTED BLAs AND BLA EFFICACY SUPPLEMENTS

Goals MDUFMA I Performance Goals Cohort Closed Received Final Performance
Overdue On Time Percent
On Time
Review and act on “Class 1” original BLA and BLA efficacy supplement resubmissions Act on 90% within 2 months Y 102 2 100 98%
Review and act on “Class 2” original BLA and BLA efficacy supplement resubmissions Act on 90% within 6 months Y 2 0 2 100%

* Numbers were updated to reflect corrections to the FY 2008 MDUFA Performance Report.


Performance for FY 2009

The table below presents FDA’s preliminary performance for reviewing and acting on biologics applications in FY 2009. As of September 30, 2009, performance data was available for over four-fifths (81 of 95) of BLA manufacturing supplement submissions and over half (15 of 29) of “Class 1” BLA and BLA efficacy supplement resubmissions (see table below). With submissions pending within goal for standard BLAs, BLA manufacturing supplement submissions, standard BLA efficacy supplement submissions, and “Class 1” BLA and BLA efficacy supplement resubmissions, FDA has the potential to exceed the performance goals in these areas for FY 2009.

BLAs

Goals MDUFMA I Performance Goals Cohort Closed Received Pending Within Goal Performance as of September 30, 2009
Overdue On Time Percent
On Time
Review and act on
priority original BLAs
Act on 90% within 6 months Y 0 -- -- -- --
Review and act on standard original BLAs Act on 90% within 10 months N 8 8 -- -- --

BLA SUPPLEMENTS

Goals MDUFMA I Performance Goals Cohort Closed Received Pending Within Goal Performance as of September 30, 2009
Overdue On Time Percent
On Time
Review and act on BLA manufacturing supplements that require prior approval Act on 90% within 4 months N 95 14 0 81 100%
Review and act on priority BLA efficacy supplements Act on 90% within 6 months Y 0 -- -- -- --
Review and act on standard BLA efficacy supplements Act on 90% within 10 months N 1 1 -- -- --

RESUBMITTED BLAs AND BLA EFFICACY SUPPLEMENTS

Goals MDUFMA I Performance Goals Cohort Closed Received Pending Within Goal Performance as of September 30, 2009
Overdue On Time Percent
On Time
Review and act on “Class 1” original BLA and BLA efficacy supplement resubmissions Act on 90% within 2 months N 29 14 0 15 100%
Review and act on “Class 2” original BLA and BLA efficacy supplement resubmissions Act on 90% within 6 months Y 0 -- -- -- --

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