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Annual On-Time Review Performance for FY 2008

FY 2008 PDUFA Performance Report Table of Contents

The table below summarizes FDA’s performance for FY 2007 and FY 2008 submissions whose reviews were completed during FY 2008. For the purposes of measuring on-time performance only, a review is considered complete either when an action is taken, or when the on-time goal period has expired, whichever occurs first. The on-time review performance for FY 2008 includes reviews that were pending and not overdue from FY 2007 and reviews that were completed on time and pending overdue in FY 2008. FDA review performance for FY 2008 ranged from 71 percent of reviews on time for priority NMEs and BLAs to 95 percent on time for manufacturing supplements not requiring prior approval.

 

Application/Submission Type On Time Goal Reviews Completed On Time During FY 2008
Submitted In FY 2007 Submitted In FY 2008 Total 
On Time / Reviewed* On Time / Reviewed* On Time / Reviewed* Percent on Time
Priority NDAs/BLAs 6 months 14 / 16 12 / 17 26 / 33 79%
    Priority NMEs/BLAs 6 months 6 / 7 6 / 10 12 / 17 71%
Standard NDAs/BLAs 10 months 69 / 79 20 / 20 89 / 99 90%
    Standard NMEs/BLAs 10 months 19 / 23 10 / 11 29 / 34 85%
Resubmitted Class I NDAs/BLAs 2 months 1 / 3 15 / 16

16 / 19

84%
Resubmitted Class 2 NDAs/BLAs 6 months 23 / 26 15 / 20 38 / 46 83%
Priority Efficacy Supplements 6 months 20 / 22 20 / 21 40 / 43 93%
Standard Efficacy Supplements 10 months 107 / 125 14 / 16 121 / 141 86%
Resubmitted Class 1 Efficacy Supplements 2 months  0 / 2 9 / 9 9 / 11 82%
Resubmitted Class 2 Efficacy Supplements 6 months 10 / 12 13 / 14 23 / 26 88%
Manufacturing Supplements Requiring Prior Approval 4 months 256 / 289 537 / 608 793 / 897 88%
Manufacturing Supplements Not Requiring Prior Approval 6 months 807 / 837 814 / 863 1,621 / 1,700 95%
   * Includes reviews that were completed on time, overdue, and pending action past goal.

 

On-time review performance in any given year will impact two fiscal years of performance goals. FY 2008 reviews were a factor in the final FY 2007 performance goal calculations and preliminary FY 2008 performance goal measurements. Likewise, final FY 2008 performance goal calculations will be dependent on FY 2009 review performance.

Next page: Performance Goals At-A-Glance: FY 2007 and FY 2008

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