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Real-Time PMA Supplements

 

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for real-time PMA supplements. Performance goals are applied to the MDUFA cohort submissions.

GoalTierReview TimePerformance Level
FY 2008 – FY 2012 Submissions
Issue a decision for real-time PMA supplements160 days80% on time
290 days90% on time

 

Workload

The number of real-time PMA supplement MDUFA cohort submissions increased by almost one-fifth from FY 2008 to FY 2009 (see corresponding graph and table).  
 

Real-Time PMA Supplements MDUFA FY 2009

Real-Time PMA Supplements

TypeFY 05FY 06FY 07FY 08FY 09
Submissions------250301
MDUFA Cohort Submissions*------241 285

* Workload for real-time PMA supplements was not reported from FY 2005 through FY 2007 and not required under MDUFMA I.
† 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 all (241 of 241) of real-time PMA supplement FY 2008 submissions and almost nine-tenths (250 of 285) of FY 2009 submissions (see table below).

  • FDA completed 92 percent (222 of 241) of submissions on time and exceeded the Tier 1 performance goal for FY 2008. FDA met the Tier 1 review-time goal for 227 of 250 submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 1 performance goal for FY 2009.
  • FDA met the Tier 2 review-time goal for 234 of 240 submissions in FY 2008 and 237 of 250 submissions in FY 2009. With submissions pending within goal, FDA will exceed the Tier 2 performance goal for FY 2008 and 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 real-time PMA supplements1Issue 80% within
60 days
2008N24101922292%
2009N285352322791%
2Issue 90% within
90 days
2008N2411623498%
2009N285351323795%

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