Drugs

Electronic Common Technical Document (eCTD)

Important Notices

eCTD Documentation and Resources

For a listing of Specifications, Supportive Files, M1 versions 1.3 and 2.3 documents related to eCTD, please refer to eCTD Data Standards (XLS - 57KB) or eCTD Data Standards (PDF - 91KB).

Guidances

ICH Documents

Technical Assistance

If you have questions for CDER, please contact CDER ESUB at esub@fda.hhs.gov.

If you have questions for CBER, please contact CBER ESUB at esubprep@fda.hhs.gov.

Page Last Updated: 07/22/2015
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