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MDUFA II Performance At-A-Glance for FY 2008 and FY 2009

FY 2009 MDUFA Performance Report Table of Contents

The table below summarizes FDA’s on-time review performance for FY 2008 and FY 2009 submissions subject to meeting MDUFA II performance goals. As of September 30, 2009, FDA was meeting or exceeding over half (7 of 12) of the Tier 1 performance goals and two-thirds (8 of 12) of the Tier 2 performance goals for the FY 2008 and FY 2009 cohorts.

 Overview of MDUFA Performance, FY 2009 Graph

Next page: Original PMAs, Panel-Track PMA Supplements, and Premarket Reports