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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

Measure was implemented starting April 2010

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 - 2010

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Measure was implemented starting April 2010

TimeTargetNumber
Apr 2010N/A8
May 2010N/A17
Jun 2010N/A13
Jul 2010N/A4
Aug 2010N/A15
Sep 2010N/A12

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

Measure was implemented starting April 2010

Fiscal Year - 2010
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Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A25
May 2010N/A47
Jun 2010N/A61
Jul 2010N/A50
Aug 2010N/A73
Sep 2010N/A58

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

Measure was implemented starting April 2010

Fiscal Year - 2010
Skip graphic and jump to text data.

Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A50
May 2010N/A24
Jun 2010N/A31
Jul 2010N/A25
Aug 2010N/A20
Sep 2010N/A17

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

Measure was implemented starting April 2010

Fiscal Year - 2010
Skip graphic and jump to text data.

Measure was implemented starting April 2010

TimeTargetPercent
Apr 2010N/A25
May 2010N/A29
Jun 2010N/A8
Jul 2010N/A25
Aug 2010N/A7
Sep 2010N/A25

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.