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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 - 2011

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TimeTargetPercent
Oct 2010N/A66
Nov 2010N/A66
Dec 2010N/A68
Jan 2011N/A67
Feb 2011N/A67
Mar 2011N/A70
Apr 2011N/A70
May 2011N/A67
Jun 2011N/A70
Jul 2011N/A72
Aug 2011N/A67
Sep 2011N/A71

Total New Drug Application (NDA) related submissions

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A1,820
Nov 2010N/A1,791
Dec 2010N/A2,158
Jan 2011N/A1,526
Feb 2011N/A1,932
Mar 2011N/A1,931
Apr 2011N/A1,930
May 2011N/A2,116
Jun 2011N/A2,010
Jul 2011N/A1,914
Aug 2011N/A1,916
Sep 2011N/A2,137

FY 2011 Total: 23,181

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.