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U.S. Department of Health and Human Services

About FDA

Number of PMRs and PMCs established during the month

Measure was implemented starting October 2010

Dictionary: Postmarket Requirements (PMR) and Commitments (PMC) are required or agreed-upon studies or trials conducted after the approval of a marketing application. The number of PMRs and PMCs established during the month reflect the number of postmarket studies or trials required for safety or requested by FDA, while the number of PMRs and PMCs fulfilled or released during the month reflects the combined total number of studies or trials fulfilled/released by both CDER and CBER in response to the required or requested PMRs and PMCs.


These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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Measure was implemented starting October 2010

TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/AN/A
May 2010N/AN/A
Jun 2010N/AN/A
Jul 2010N/AN/A
Aug 2010N/AN/A
Sep 2010N/AN/A

Number of PMRs and PMCs fulfilled or released during the month

Measure was implemented starting April 2010

Dictionary: Postmarket Requirements (PMR) and Commitments (PMC) are required or agreed-upon studies or trials conducted after the approval of a marketing application. The number of PMRs and PMCs established during the month reflect the number of postmarket studies or trials required for safety or requested by FDA, while the number of PMRs and PMCs fulfilled or released during the month reflects the combined total number of studies or trials fulfilled or released by both CDER and CBER in response to the required or requested PMRs and PMCs.

Fiscal Year - 2010

Skip graphic and jump to text data

Measure was implemented starting April 2010

TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/AN/A
Feb 2010N/AN/A
Mar 2010N/AN/A
Apr 2010N/A8
May 2010N/A14
Jun 2010N/A13
Jul 2010N/A19
Aug 2010N/A16
Sep 2010N/A3

Footnotes

  • Data reflects the combined total number of PMRs and PMCs fulfilled or received by both CDER and CBER.

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.