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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 - 2012

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TimeTargetNumber
Oct 2011N/A6
Nov 2011N/A11
Dec 2011N/A10
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: 27

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 - 2012
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TimeTargetPercent
Oct 2011N/A66
Nov 2011N/A82
Dec 2011N/A50
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

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 - 2012
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TimeTargetPercent
Oct 2011N/A17
Nov 2011N/A9
Dec 2011N/A30
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

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

Fiscal Year - 2012
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TimeTargetPercent
Oct 2011N/A17
Nov 2011N/A9
Dec 2011N/A20
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

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.