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U.S. Department of Health and Human Services

About FDA

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 - 2011

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TimeTargetNumber
Oct 2010N/A49
Nov 2010N/A23
Dec 2010N/A2
Jan 2011N/A24
Feb 2011N/A16
Mar 2011N/A39
Apr 2011N/A38
May 2011N/A48
Jun 2011N/A37
Jul 2011N/A29
Aug 2011N/A36
Sep 2011N/A10

FY 2011 Total: 351

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 - 2011

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TimeTargetNumber
Oct 2010N/A20
Nov 2010N/A22
Dec 2010N/A11
Jan 2011N/A12
Feb 2011N/A15
Mar 2011N/A15
Apr 2011N/A14
May 2011N/A14
Jun 2011N/A18
Jul 2011N/A13
Aug 2011N/A17
Sep 2011N/A18

FY 2011 Total: 189

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.