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U.S. Department of Health and Human Services

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Number of submissions with electronic datasets reaching mid-cycle review during the month

Dictionary: These measures have 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/A6
Nov 2010N/A7
Dec 2010N/A5
Jan 2011N/A7
Feb 2011N/A8
Mar 2011N/A11
Apr 2011N/A3
May 2011N/A15
Jun 2011N/A10
Jul 2011N/A6
Aug 2011N/A6
Sep 2011N/A9

FY 2011 Total: 93

Percent of submissions reaching mid-cycle review during the month that required minimal or no additional data management prior to performing analyses and no requests for additional datasets were made to sponsor

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A33
Nov 2010N/A29
Dec 2010N/A60
Jan 2011N/A86
Feb 2011N/A25
Mar 2011N/A36
Apr 2011N/A100
May 2011N/A53
Jun 2011N/A50
Jul 2011N/A83
Aug 2011N/A17
Sep 2011N/A56

Percent of submissions reaching mid-cycle review during the month that required additional data management prior to performing analyses, but no requests for additional datasets were made to the sponsor

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A50
Nov 2010N/A42
Dec 2010N/A20
Jan 2011N/A14
Feb 2011N/A25
Mar 2011N/A27
Apr 2011N/A0
May 2011N/A20
Jun 2011N/A20
Jul 2011N/A0
Aug 2011N/A17
Sep 2011N/A22

Percent of submissions reaching mid-cycle review during the month that required additional data requests to sponsor for adequate analysis datasets

Fiscal Year - 2011
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TimeTargetPercent
Oct 2010N/A17
Nov 2010N/A29
Dec 2010N/A20
Jan 2011N/A0
Feb 2011N/A50
Mar 2011N/A36
Apr 2011N/A0
May 2011N/A27
Jun 2011N/A30
Jul 2011N/A17
Aug 2011N/A66
Sep 2011N/A22

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.