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Report on Final MDUFMA I Performance

FY 2009 MDUFA Performance Report Table of Contents

This section presents FDA’s final performance for MDUFMA I cohorts for FY 2004 through FY 2007 as of September 30, 2009. [6] The following information refers to FDA performance presented in this section.

  • Review performance statistics are based on a fiscal year receipt cohort. This methodology calculates performance statistics for the fiscal year submissions that were received, regardless of when FDA acted on the submissions. As more submissions are completed, the statistics for that fiscal year of receipt are updated to reflect completed actions. A result of this approach is that the statistics shown for a particular fiscal year may be subject to updates from one annual report to the next as FDA continues to act on submissions.
  • A decision goal is a goal on a final action that ends the review process.
  • FDA will report annually on MDUFMA I decision goals until each fiscal year cohort is reported closed or the remaining submissions are past the due date, whereby, FDA is able to determine final performance. Once the cohort is reported closed or final performance is provided, FDA will not repeat the information in future annual user fee performance reports. Until submissions in a cohort receive a final decision or are pending past the goal date, whichever comes first, a preliminary performance assessment is provided for that cohort.
  • Performance is based on the number of submissions reviewed “on time” (acted on within goal) and “overdue” (acted on past the goal or pending past the goal date) and presented as “percent on time.”
  • All references to days are the number of days FDA reviewed the document, not counting time periods where an application was on hold waiting for additional information requested from the sponsor.
  • Performance tables indicate if the fiscal year cohort is closed with a “Y” for yes and an “N” for no.
  • FY 2007 is treated as a transition period from MDUFMA I to MDUFA II. Therefore, the FY 2007 cohort is reported separately from the FY 2004 through FY 2006 cohorts.
[6] The FY 2003 cohort was closed in the previously published FY 2008 MDUFA Performance Report and, therefore, is not reported in this FY 2009 MDUFA Performance Report.

Next page: Performance for MDUFMA I Cohorts for FY 2004 through FY 2006