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.

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: 05/11/2015
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