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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 December 31, 2014.

Fiscal Year - 2015

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TimeTargetPercentage
Oct 20148081
Nov 20148087
Dec 20148087
Jan 201580TBD
Feb 201580TBD
Mar 201580TBD
Apr 201580TBD
May 201580TBD
Jun 201580TBD
Jul 201580TBD
Aug 201580TBD
Sep 201580TBD

FY 2015 YTD Percentage: 85

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 - 2015
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TimeTargetNumber
Oct 2014N/A2,334
Nov 2014N/A1,925
Dec 2014N/A2,361
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 6,620

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.