Original PMAs, Panel-Track PMA Supplements, and Premarket Reports
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.
|Goal||Tier||Review Time||Performance Level|
FY 2008 – FY 2012 Submissions
|Issue a decision for non-expedited|
|1||180 days||60% on time|
|2||295 days||90% on time|
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).
PMAs, Panel-Track PMA Supplements, and Premarket Reports
|Type||FY 05||FY 06||FY 07||FY 08||FY 09|
|MDUFA Cohort Submissions||57||56||37||32*||39|
* FY 2008 number was updated to reflect a correction to the FY 2008 MDUFA Performance Report.
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.
|Fiscal Year||Cohort Closed||Received||Pending|
|Overdue||On Time||Percent |
|Issue a decision for |
non-expedited filed submissions
|1||Issue 60% within |
|2||Issue 90% within |