Review Performance Presented in This Report

FY 2009 AGDUFA Performance Report Table of Contents

In any given year, FDA performance includes reviews of applications and submissions pending from previous fiscal years along with submissions received during the current fiscal year. This report presents FDA on-time review performance for actions submitted and completed in FY 2009.

On-Time Review of AGDUFA Applications. FDA on-time review performance is presented for each application or submission type to provide an indication on how FDA is performing within a given fiscal year. This report provides a snapshot of on-time review performance for AGDUFA reviews completed or due for completion during FY 2009. Included are FY 2009 submissions that were received early enough in FY 2009 to be reviewed or due for review (see column A in table below).

AGDUFA Performance Goals. AGDUFA review time goals for FY 2009 range from 120 days to 700 days. To meet AGDUFA performance goals, FDA must meet review time goals at least 90 percent of the time for a defined group of applications and submissions. FDA will annually report on the performance goal results for any given fiscal year cohort (as defined from October 1 and continuing to September 30 of the following year). For applications and submissions received too late to be reviewed by the end of the fiscal year, these applications and submissions will be reported on after FDA takes action, or the goal review time period expires (pending overdue), whichever comes first. When determining FDA performance, calculated percentages are rounded to the nearest whole number up to 99 percent. Percentages above 99 percent, but below 100 percent, are rounded down to 99 percent. Preliminary performance goal results presented in this report are for FY 2009 cohort submissions that were acted on or pending overdue as of September 30, 2009 (see column A). FDA will report on FY 2009 cohort submissions that were acted on or overdue as of September 30, 2010 (column B) in the FY 2010 performance report with final FY 2009 performance results (column C) reported in the FY 2011 performance report.

Next page: On-Time Review Performance for FY 2009