On-Time Review Performance FY 2009

FY 2009 AGDUFA Performance Report Table of Contents

This section summarizes FDA’s on-time review performance for actions completed or due in FY 2009, regardless of the year of submission. On-time review performance provides a snapshot of FDA’s overall on-time review performance for the given fiscal year. On-time review performance is based on how well FDA met review time goals during the fiscal year and provides an indication of how well FDA is performing during that fiscal year. However, it does not provide performance with respect to meeting or exceeding AGDUFA performance goals. AGDUFA performance goals are based on the fiscal year cohort of submission, combine on-time review performance with FDA commitments to meet specified performance goal levels, and are presented in the next section.

FDA can now report:

• A total of 14 AGDUFA applications and submissions had reviews completed in FY 2009.
• No reviews were overdue as of September 30, 2009.
• All reviews met the on-time review goals defined under AGDUFA.

FDA also completed work during FY 2009 on 537 applications and submissions that were in backlog status. However, these applications and submissions were not subject to AGDUFA on-time review goals.

The table below summarizes FDA’s on-time review performance for FY 2009.

* Does not include reviews completed to address backlog applications and submissions prior to AGDUFA.
† Includes total number of reviews that were completed (on time or past the goal) and submissions still pending action but overdue.

Next page: Report on Preliminary FY 2009 AGDUFA Performance Goal Cohort Performance