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180-Day PMA Supplements

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for 180-day PMA supplements. Performance goals are applied to the MDUFA cohort submissions.
 

Goal Tier Review Time Performance Level
FY 2008 – FY 2012 Submissions
Issue a decision for 180-day PMA supplements 1 180 days 85% on time
2 210 days 95% on time

 

Workload

The number of 180-day PMA supplement MDUFA cohort submissions reached a 4-year high in FY 2008 and remained at that level in FY 2009 (see corresponding graph and table).

180-Day PMA Supplements MDUFA FY 2009

 

180-Day PMA Supplements

Type FY 05 FY 06 FY 07 FY 08 FY 09
Submissions 101 137 142 175 170
MDUFA Cohort Submissions 101 137 142 167* 167

* 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 virtually all (163 of 167) of the 180-day PMA supplement FY 2008 submissions and half (83 of 167) of FY 2009 submissions (see table below).

  • FDA met the Tier 1 review-time goal for 147 of 163 submissions in FY 2008 and 80 of 83 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 156 of 163 submissions in FY 2008 and all (81 of 81) submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 2 performance goal for FY 2008 and FY 2009.
Goal Tier Performance
Goals		 Fiscal Year Cohort Closed Received Pending
Within Goal		 Overdue On Time Percent
On Time
Issue a decision for 180-day PMA supplements 1 Issue 85% within
180 days		 2008 N 167 4 16 147 90%
2009 N 167 84 3 80 96%
2 Issue 95% within
210 days		 2008 N 167 4 7 156 96%
2009 N 167 86 0 81 100%

Next page: Real-Time PMA Supplements

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