Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

Procedural and Processing Goals – Special Protocol Assessments

FY 2008 PDUFA Performance Report Table of Contents

The table below summarizes the annual review time and performance goals for the response to the requests for special protocol assessments.

Action Review Time Goal Performance Goal
FY 2008 – FY 2012
Special Protocol Question Assessment and Agreement Respond to sponsor's request for evaluation of protocol design within 45 days of receipt. 90% on time

 

Workload

In FY 2008, special protocol assessment requests reversed a three-year trend of increases, decreasing to levels close to FY 2004 (see corresponding graph and table).

 

Requests for Special Protocol Assessments

 

Requests for Special Protocol Assessments

FY 04 FY 05 FY 06 FY 07* FY 08
346 396 406 459 354

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


FY 2008 Performance 

As of September 30, 2008, performance data was available for over four-fifths (313 of 354) of the sponsors’ requests for evaluation of protocol designs received in FY 2008, and FDA was not meeting the performance goal (see table below). With 41 assessments pending action and not overdue, FDA can increase performance, but not enough to meet the performance goal.

Performance Goal Total Received Performance as of September 30, 2008 Highest Potential Performance
On Time Overdue Percent On Time Pending On Time On Time Percent On Time
Respond to 90 percent within 45 Days 354 269 44 86% 41 310 88%

Next page: Responses to Clinical Holds

-
-