• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 - 2012

Skip graphic and jump to text data

TimeTargetPercent
Oct 20119096
Nov 20119098
Dec 20119096
Jan 20129096
Feb 20129095
Mar 201290100
Apr 20129098
May 20129096
Jun 20129091
Jul 201290100
Aug 20129098
Sep 20129089

FY 2012 Overall: 96%

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A47
Nov 2011N/A51
Dec 2011N/A53
Jan 2012N/A49
Feb 2012N/A55
Mar 2012N/A50
Apr 2012N/A48
May 2012N/A54
Jun 2012N/A60
Jul 2012N/A49
Aug 2012N/A64
Sep 2012N/A33

FY 2012 Total: 613

Total number of PAS decision letters completed during the month

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A49
Nov 2011N/A52
Dec 2011N/A55
Jan 2012N/A51
Feb 2012N/A58
Mar 2012N/A50
Apr 2012N/A49
May 2012N/A56
Jun 2012N/A66
Jul 2012N/A49
Aug 2012N/A65
Sep 2012N/A37

FY 2012 Total: 637

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.