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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 - 2012

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TimeTargetPercent
Oct 2011N/A74
Nov 2011N/A74
Dec 2011N/A72
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

Total New Drug Application (NDA) related submissions

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A2,509
Nov 2011N/A1,985
Dec 2011N/A2,132
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 6,626

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.