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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 - 2012

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TimeTargetPercentage
Oct 201180N/A
Nov 201180N/A
Dec 201180N/A
Jan 201280N/A
Feb 201280N/A
Mar 201280N/A
Apr 201280N/A
May 201280N/A
Jun 201280N/A
Jul 20128074
Aug 20128077
Sep 20128076

FY 2012 3 month Overall: 76%

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 - 2012
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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A1,739
Aug 2012N/A2,154
Sep 2012N/A1,794

FY 2012 3 month Total: 5,687

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.