Report on Preliminary FY 2009 AGDUFA Performance Goal Cohort Performance

FY 2009 AGDUFA Performance Report Table of Contents

This report presents FDA's review performance in FY 2009 for AGDUFA performance goals and commitments as of September 30, 2009. The following information refers to FDA performance presented in this report.

• The term submission is used to refer to ANADAs and reactivations, supplemental ANADAs and reactivations, JINAD studies, and JINAD protocols when referencing the fiscal year cohort.
• Review time goals are the targeted time period identified in number of days for when individual submissions are to be acted on. An on-time review indicates that action was completed within the number of days specified by the review time goal.
• Percent on time refers to the percent of reviews where FDA met a review time goal for a given type of submission. FDA’s percent on time for a given type of submission is used to determine FDA’s performance, and whether FDA met or exceeded the AGDUFA performance goal.
• Performance goals are the percent of total submissions, agreed to under AGDUFA, where FDA is expected to meet the review time goal for a given type of submission. AGDUFA performance goals are established for FDA to meet the review time goals 90 percent of the time for the defined fiscal year cohort.
• Review performance statistics are based on a fiscal year receipt cohort. This methodology calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. A result of this approach is that the statistics shown for a particular year may change from one report to the next. This is because, as time passes, FDA completes work on more submissions in a receipt cohort. As more submissions are completed, the statistics for that year of receipt are adjusted to reflect the new completions. Therefore, until all submissions in a cohort are acted on or past the due date, whichever comes first, only a preliminary performance assessment is provided for that cohort.
• Only a preliminary performance assessment is possible on applications and submissions received and acted on during FY 2009. For submissions with a review goal that is shorter, for example, 120 days, individual review performance data may be available for the majority of the cohort. When this happens, preliminary review performance data may be a valid indicator of overall goal performance. However, for submission categories with a longer review goal, for example, 400 days or longer, early review performance data is usually limited.
• The workload count for FY 2009 includes all applications and submissions received in the last month of FY 2009 as filed (e.g., ANADA) or submitted (e.g., JINAD). FDA makes a filing decision within 30 days of receiving an original application, or a proceed-to-review decision within 60 days of receiving a submission. FDA calculates AGDUFA review times, however, from the original receipt of the application or submission.
• Applications and submissions that FDA identified as refused to file or withdrawn, and reviews that were stopped at the request of the sponsor (applies to JINAD submissions only) are not included in the statistics used to measure performance. These applications and submissions are noted, however, in the relevant workload narratives and footnotes for performance goals.

Next page: Review Performance Goals At-A-Glance for FY 2009 Cohort