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First Cycle Filing Review Notification

FY 2008 PDUFA Performance Report Table of Contents

Goal: Report Substantive Deficiencies (or Lack of Same) Within 14 Days After the 60-Day Filing Date for Original NDAs/BLAs and Efficacy Supplements

The table below summarizes the annual review time goals for first cycle filing review notifications for original NDAs/BLAs, and efficacy supplements. FDA is to report substantive deficiencies (or lack of same) identified during the initial filing review to the sponsor by letter, telephone conference, facsimile, secure e-mail, or other expedient means within 14 days after the 60-day filing date.

First Cycle Filing Review Notification Type Review Time Goal Performance Goal
FY 08 FY 09 FY 10 FY 11 FY 12
Original NDAs/BLAs Within 14 days after 60-day filing date 90% on time
Efficacy Supplements

 

Workload

The number of first cycle filings for NDAs fluctuated over the past 5 years, returning in FY 2008 to near the FY 2004 level. BLAs decreased in FY 2008, but remained at a level higher than FY 2004 to FY 2006. Efficacy supplements decreased in FY 2008 to their lowest levels in 5 years (see corresponding graph and table).

First Cycle Filings for Original NDAs, BLAs, and Efficacy Supplements PDUFA FY 2008

First Cycle Filings

Type FY 04 FY 05 FY 06 FY 07* FY 08
NDAs 123 102 111 95 122
BLAs 9 9 12 20 18
Total NDAs and BLAs 132 111 123 115 140
Efficacy Supplements† 147 124 142 148 115

*  FY 2007 counts were updated to reflect corrections to the FY 2007 Performance Report.

† The First Cycle Filing Review Notification goal applies to original NDAs/BLAs and efficacy supplements only. It does not apply to NDA labeling supplements that contain clinical data, even though these are counted as efficacy supplements for other PDUFA performance purposes. Therefore, the number of filing review notifications for efficacy supplements is less than the total number of efficacy supplements filed (as shown on page 18).


Performance

FY 2007 Submissions

FDA issued first cycle filing review notifications on time for almost all (109 of 115) of NDAs/BLAs and most efficacy supplements filed in FY 2007 (see table below). FDA exceeded the performance goal for NDAs/BLAs but did not meet the performance goal for efficacy supplements.

First Cycle Filing Review Notification Type Performance Goal Filed  Performance as of September 30, 2007 Final Performance as of September 30, 2008
On Time Overdue Percent On Time On Time Overdue Percent On Time
NDAs/BLAs Within 14 days after 60-day filing date 115 90 5 95% 109 6 95%
Efficacy Supplements 148 95 8 92% 126 22 85%


FY 2008 Submissions

As of September 30, 2008, first cycle performance data was available for over four-fifths (118 of 140) of NDAs/BLAs filed in FY 2008, and FDA was not meeting the performance goal (see table below). With 22 NDA/BLA notifications pending and not overdue, FDA can increase performance but not enough to meet the performance goal. Performance data was available for over four-fifths (101 of 115) of efficacy supplements filed in FY 2008, and FDA was not meeting the performance goal. With 14 efficacy supplement notifications pending and not overdue, FDA can increase performance but not enough to meet the performance goal.

First Cycle Filing Review Notification Type Performance Goal Filed Performance as of September 30, 2008 Highest Potential Performance
On Time  Overdue Percent On Time Pending On Time On Time Percent On Time
NDAs/BLAs Within 14 days after 60-day filing date 140 101 17 86% 22 123 88%
Efficacy Supplements 115 82 19 81% 14 96 83%

Next page: PDUFA IV Management Initiatives Accomplishments

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