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U.S. Department of Health and Human Services

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Percent of NDA related submissions in eCTD format in the month

Dictionary: The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information based on internationally recognized standards. eCTD is the preferred format for electronic submissions.


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 - 2010

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TimeTargetPercent
Oct 2009N/A60
Nov 2009N/A59
Dec 2009N/A58
Jan 2010N/A62
Feb 2010N/A59
Mar 2010N/A61
Apr 2010N/A64
May 2010N/A66
Jun 2010N/A64
Jul 2010N/A65
Aug 2010N/A65
Sep 2010N/A65

Total New Drug Application (NDA) related submissions

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A1,848
Nov 2009N/A1,889
Dec 2009N/A1,979
Jan 2010N/A1,519
Feb 2010N/A1,718
Mar 2010N/A1,932
Apr 2010N/A1,889
May 2010N/A1,971
Jun 2010N/A2,005
Jul 2010N/A1,891
Aug 2010N/A1,815
Sep 2010N/A1,790

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.