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Procedural and Processing Goals – Meeting Management

FY 2008 PDUFA Performance Report Table of Contents

The table below summarizes the meeting management goals that address meeting requests, scheduling meetings, and preparing meeting minutes.

 

Action Review Time Goal Performance Goal
FY 2008 – FY 2012
Meeting Requests Notify requestor of formal meeting in writing within 14 days of request. 90% on time
Scheduling Meetings Schedule meetings within goal date (within 30 days of receipt of request for Type A meetings, 60 days for Type B meetings, and 75 days for Type C meetings).* If the requested date for any of these types of meetings is greater than 30, 60, or 75 days, as appropriate, from the date the request is received by FDA, the meeting date should be within 14 days of the requested date.
Meeting Minutes FDA-prepared minutes, clearly outlining agreements, disagreements, issues for further discussion, and action items will be available to the sponsor within 30 days of meeting.

* Defined in the “Definition of Terms” in Appendix A.

Workload

The number of meeting management activities continued to decrease in FY 2008. Meeting requests and scheduling of meetings have decreased for two straight years and meeting minutes have decreased for three straight years (see corresponding graph and table).

Meeting Management Trends

Meeting Management  

Type FY 04 FY 05 FY 06 FY 07 FY 08
Meeting Request  Notifications 2,284 2,487 2,565 2,502 2,344
Scheduling Meetings 2,125 2,230 2,273 2,151 1,903
Meeting Minutes 1,854 1,901 1,853 1,736 1,515

 

FY 2008 Performance

As of September 30, 2008, FDA was not meeting performance goals for meeting management in FY 2008 (see table below). With activities still pending action and not overdue, completing these activities on time will increase overall performance in most areas, but not enough to meet review time goals.

 

Type Performance  Goal –  Review 90 percent within  Received Performance as of September 30, 2008  Highest Potential Performance
On Time Overdue Percent On Time Pending On Time On Time  Percent  On Time
Meeting Requests Type A 14 Days 362 216 128 63% 18 234 65%
Type B 21 Days 1,330 1,086 231 83% 13 1,099  83%
Type C 652 517 124 81% 11 528  81%
Scheduling Meetings* Type A 30 Days 260 128 91 58% 41 169 65%
Type B 60 Days 1,157 852 259 77% 46 898 78%
Type C 75 Days 486 361 96 79% 29 390 80%
Meeting Minutes 30 Days 1,515 789 516 61% 210 999 66%

* Not all meeting requests are granted.

Next page: Special Protocol Assessments

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