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Expedited Original PMAs and Panel-Track PMA Supplements

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for expedited original PMAs and panel-track 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 expedited
filed submissions
1 180 days 50% on time
2 280 days 90% on time

 

Workload

The number of expedited PMA and panel-track PMA supplement MDUFA cohort submissions decreased in FY 2009 to the same number of submissions received in FY 2006 and FY 2007 (see corresponding graph and table). 

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

Expedited PMAs and Panel-Track PMA Supplements

Type FY 05 FY 06 FY 07 FY 08 FY 09
Submissions 6 2 2 4 2
MDUFA Cohort Submissions* 6 2 2 4 2

* Only workload for expedited PMAs was reported on from FY 2005 through FY 2007. Workload for expedited panel-track PMA supplements was not reported during this time and not required under MDUFMA I. 

 

Performance

As of September 30, 2009, performance data was available for all (4 of 4) of expedited filed FY 2008 submissions and half (1 of 2) of FY 2009 submissions (see table below). The total number of expedited filed submissions received for the FY 2008 (four) and FY 2009 (two) cohorts combined is less than ten. When this occurs, FDA will present on-time review performance but will delay reporting on performance with respect to performance goals until combined consecutive cohort numbers reach a total of ten submissions.[7].

  • FDA met the Tier 1 review-time goal for 1 of 4 submissions in FY 2008 and did not meet the Tier 1 review-time goal for the single submission in FY 2009.
  • FDA met the Tier 2 review-time goal for 2 of 3 submissions in FY 2008.
Goal Tier Performance
Goals
Fiscal Year Cohort Closed Received Pending
Within Goal
Overdue On Time Percent
On Time
Issue a decision for expedited filed submissions 1 Issue 50% within
180 days
2008 N 4 0 3 1 25%
2009 N 2 1 1 0 0%
2 Issue 90% within
280 days
2008 N 4 1 1 2 67%
2009 N 2 2 0 0 --

[7]When the number of submissions granted expedited review is less than ten in any one fiscal year, FDA combines the submissions for the following fiscal year(s) in order to form a cohort of ten submissions upon which FDA is then held to the performance goals.

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