Report on FY 2007 and FY 2008 PDUFA Goals

FY 2008 PDUFA Performance Report Table of Contents

This section updates FDA’s final review performance on the FY 2007 submissions and evaluates FDA’s preliminary performance in reviewing FY 2008 submissions and meeting other PDUFA performance goals. The following information refers to FDA performance presented in this section.

• Preliminary performance is based on the number of submissions reviewed “on time” (acted on within goal) and “overdue” (acted on or pending past the goal date) along with the “percent on time” (preliminary performance). Final performance includes the final number of submissions on time (acted on within goal) and overdue (acted on or pending past goal) along with the percent on time (final performance).
• Final performance data was available on over 99 percent (3,089 of 3,096) of FY 2007 submissions and resubmissions. Overdue submissions were included in all final FY 2007 performance determinations and final performance with respect to achieving FY 2007 goals can now be reported.
• The counts for FY 2008 include submissions received in the last 2 months of FY 2008 and filed. When FDA files a submission, it is deemed “complete” using the PDUFA definition. FDA makes a filing decision within 60 days of an original application’s receipt. All PDUFA review times are calculated from the original receipt date of the submission.
• A preliminary performance assessment based on 30 percent (863 of 2,895) of FY 2008 submissions and resubmissions is included in this report. Submissions with short (for example, 2 months) performance goals tend to have most reviews completed by the end of the fiscal year and their preliminary performance is generally close to their potential final performance. However, submissions with longer (for example, 10 months) performance goals tend to have less reviews completed and their preliminary performance may not be as close to the potential final performance.
• Preliminary performance for FY 2008 submissions includes the number of submissions filed or received, reviewed on time, and overdue by the end of the current fiscal year, as well as the number pending on time (within goal). Additionally, the highest number of potential on-time submissions is included with the highest potential percent on time given that all pending reviews end up as being completed on time.
• The following terminology is used throughout this document: “application” means new, original application; “supplement” means supplement to an approved application; “resubmission” means resubmitted application or supplement; New Molecular Entity (NME) refers only to NMEs that are NDAs; and “submission” applies to all of the above.
• The counts of NMEs in workload tables are of “discrete” filed NMEs. FDA often receives multiple submissions for the same NME, for different dosage forms for example. All are initially designated as NMEs, but when FDA approves the first of the multiple submissions, FDA redesignates the others as non-NMEs.
• Unless otherwise noted, all performance data are as of September 30, 2008.

Next page: Review Performance Presented in This Report