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U.S. Department of Health and Human Services

About FDA

Percentage of NDA related submissions in eCTD format

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.

Information is current as of September 30, 2014.

Fiscal Year - 2013

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TimeTargetPercentage
Oct 20128076
Nov 20128078
Dec 20128078
Jan 20138075
Feb 20138079
Mar 20138076
Apr 20138079
May 20138077
Jun 20138080
Jul 20138077
Aug 20138078
Sep 20138080

FY 2013 Overall: 78%

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Total number of NDA related submissions

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A1,873
Nov 2012N/A1,816
Dec 2012N/A1,965
Jan 2013N/A1,944
Feb 2013N/A1,902
Mar 2013N/A2,008
Apr 2013N/A1,952
May 2013N/A2,122
Jun 2013N/A1,813
Jul 2013N/A1,773
Aug 2013N/A1,849
Sep 2013N/A1,716

FY 2013 Total: 22,733

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.