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U.S. Department of Health and Human Services

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Procedural and Processing Goals – Responses to Clinical Holds

FY 2008 PDUFA Performance Report Table of Contents

The table below summarizes the annual review time and performance goals for the response to clinical holds.

Action Review Time Goal Performance Goal
FY 2008 – FY 2012
Response to Clinical Hold Respond to sponsor’s complete response to a clinical hold within 30 days of receipt. 90% on time

Workload
The number of responses to clinical holds increased by 22 percent in FY 2008. This represented the third increase in 3 years and the highest level in 5 years (see corresponding graph and table).

Responses to Clinical Holds Graph

Responses to Clinical Holds

FY 04 FY 05 FY 06 FY 07* FY 08
135 130 145 175 213

* 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 almost all (200 of 213) of sponsors’ complete responses to clinical holds received in FY 2008, and FDA was not meeting the performance goal (see table below). With 13 responses pending and not overdue, FDA can increase performance, but not enough to meet the 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 30 Days 213 165 35 83% 13 178 84%

Next page: Major Dispute Resolutions

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