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Number of PMRs and PMCs established during the month

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 - 2012

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TimeTargetNumber
Oct 2011N/A22
Nov 2011N/A25
Dec 2011N/A7
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 54

Number of PMRs and PMCs fulfilled or released during the month

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 - 2012

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TimeTargetNumber
Oct 2011N/A8
Nov 2011N/A2
Dec 2011N/A11
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 21

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.