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U.S. Department of Health and Human Services

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Percent of Post-Approval Study (PAS) decision letters completed within established time frames during the month

Dictionary: The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. This program is critical for identifying side effects that were not identifiable during the premarket testing phase. This measure evaluates CDRH’s timeliness in issuing decision letters for various stages of the post-approval commitments, including post-approval protocols and reviews of interim and final study reports.

Information is current as of September 30, 2013

Fiscal Year - 2011

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TimeTargetPercent
Oct 201090100
Nov 20109097
Dec 201090100
Jan 201190100
Feb 20119095
Mar 201190100
Apr 20119098
May 20119096
Jun 20119098
Jul 20119096
Aug 201190100
Sep 20119098

FY 2011 Overall: 98%

Number of PAS decision letters completed within established time frames during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A41
Nov 2010N/A32
Dec 2010N/A45
Jan 2011N/A38
Feb 2011N/A41
Mar 2011N/A40
Apr 2011N/A50
May 2011N/A55
Jun 2011N/A50
Jul 2011N/A43
Aug 2011N/A35
Sep 2011N/A51

FY 2011 Total: 521

Total number of PAS decision letters completed during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A41
Nov 2010N/A33
Dec 2010N/A45
Jan 2011N/A38
Feb 2011N/A43
Mar 2011N/A40
Apr 2011N/A51
May 2011N/A57
Jun 2011N/A51
Jul 2011N/A45
Aug 2011N/A35
Sep 2011N/A52

FY 2011 Total: 531

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.