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Review Performance Presented in the Report

FY 2008 PDUFA Performance Report Table of Contents

In any given year, performance includes reviews ongoing from the prior fiscal year combined with submissions received during the current fiscal year. PDUFA review performance goals range from 2 months to 10 months. During each fiscal year (starting October 1 and continuing to September 30 of the following year) FDA performance can be measured for each application or submission type to provide an indication on how FDA is performing within a given fiscal year. Performance in a given fiscal year can indicate the impact of that fiscal year’s performance on the 2 years of performance goals that the reviews are associated with. This report includes performance for FY 2007 and FY 2008 submissions (see table below).

 

  Review Within FY 2007 Review [A]
FY 2008 Review		 FY 2009 Review
[ B ]
FY 2007 Submissions		 Two (2) Months ● ● ● ● ● ● ●                      
Four (4) Months ● ● ● ● ● ● ● ●                    
Six (6) Months ● ● ● ● ● ● ● ● ●                  
Ten (10) Months ● ● ● ● ● ● ● ● ● ●                
[ C ]
FY 2008 Submissions		 Two (2) Months             ● ● ● ● ● ● ●          
Four (4) Months             ● ● ● ● ● ● ● ●        
Six (6) Months             ● ● ● ● ● ● ● ● ●      
Ten (10) Months             ● ● ● ● ● ● ● ● ● ●    

Shaded area indicates results covered in this report.

Circles (●) represent 2 month review segments and illustrate potential cohort time spans depending on when submission was received during FY.

D 

[ A ] FY 2008 Annual On-Time Review Performance. Annual FY 2008 performance information in this report includes on-time review results for FY 2007 submissions carried over and reviewed during FY 2008 as well as FY 2008 submissions reviewed and acted on or pending overdue. On-time review performance provides a measure of FDA overall performance on an annual basis but does not indicate FDA performance related to PDUFA performance goals.

[ B ] FY 2007 PDUFA Performance Goals. Performance goal results are presented for all FY 2007 submissions and include reviews completed in FY 2007 and FY 2008.  This is the final report for FY 2007 submissions related to PDUFA performance goals.

[ C ] FY 2008 PDUFA Performance Goals. Performance goal results are presented only for FY 2008 submissions that were acted on in FY 2008, or that were pending overdue as of the final day of FY 2008. FY 2008 submissions that were pending within goal as of the final day of FY 2008 will be reported on in the FY 2009 PDUFA Performance Report. This is a preliminary report for FY 2008 submissions related to PDUFA performance goals.

Next page: Annual On-Time Performance for FY 2008

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