Procedural and Processing Goals – Responses to Clinical Holds
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|
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
|FY 04||FY 05||FY 06||FY 07*||FY 08|
* 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%|
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