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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 - 2010

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TimeTargetPercent
Oct 20099083
Nov 20099090
Dec 20099089
Jan 20109089
Feb 20109098
Mar 20109094
Apr 20109092
May 20109093
Jun 201090100
Jul 20109095
Aug 201090100
Sep 20109098

FY 2010 Overall: 93%

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A38
Nov 2009N/A43
Dec 2009N/A55
Jan 2010N/A42
Feb 2010N/A43
Mar 2010N/A50
Apr 2010N/A44
May 2010N/A27
Jun 2010N/A45
Jul 2010N/A54
Aug 2010N/A32
Sep 2010N/A46

FY 2010 Total: 519

Total number of PAS decision letters completed during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A46
Nov 2009N/A48
Dec 2009N/A62
Jan 2010N/A47
Feb 2010N/A44
Mar 2010N/A53
Apr 2010N/A48
May 2010N/A29
Jun 2010N/A45
Jul 2010N/A57
Aug 2010N/A32
Sep 2010N/A47

FY 2010 Total: 558

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.