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Original PMAs, Panel-Track PMA Supplements, and Premarket Reports

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for original PMAs, panel-track PMA supplements, and premarket reports. Performance goals are applied to the MDUFA cohort submissions.
 

GoalTierReview TimePerformance Level
FY 2008 – FY 2012 Submissions
Issue a decision for non-expedited
filed submissions
1180 days60% on time
2295 days90% on time

 

Workload

The number of PMA, panel-track PMA supplement, and premarket report MDUFA cohort submissions in FY 2009 represented the first increase after 3 years (FY 2006 through FY 2008) of decreases (see corresponding graph and table).

Original PMAs, Panel-Track PMA Supplements, and Premarket Reports MDUFA FY 2009

PMAs, Panel-Track PMA Supplements, and Premarket Reports

TypeFY 05FY 06FY 07FY 08FY 09
Submissions5756373339
MDUFA Cohort Submissions575637 32*39

* FY 2008 number was updated to reflect a correction to the FY 2008 MDUFA Performance Report.

 

Performance

As of September 30, 2009, performance data was available for over four-fifths (28 of 32) of non-expedited filed FY 2008 submissions and over one-tenth (5 of 39) of FY 2009 submissions (see table below).

  • FDA met the Tier 1 review-time goal for 16 of 28 submissions in FY 2008 and 3 of 5 submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 1 performance goal for FY 2008 and FY 2009.
  • FDA met the Tier 2 review-time goal for 19 of 25 submissions in FY 2008 and all (3 of 3) of the submissions in FY 2009. With submissions pending within goal, FDA can improve performance, but cannot meet the Tier 2 performance goal for FY 2008. However, FDA has the potential to exceed the Tier 2 performance goal for FY 2009.
     
GoalTier Performance
Goals
Fiscal YearCohort ClosedReceivedPending
Within Goal
OverdueOn TimePercent
On Time
Issue a decision for
non-expedited filed submissions
1Issue 60% within
180 days
2008N324121657%
2009N39342360%
2Issue 90% within
295 days
2008N32761976%
2009N393603100%

Next page: Expedited Original PMAs and Panel-Track PMA Supplements