U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
FDA eCTD Overview and Submission WBT
Background on eCTD Standard
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Module Introduction/Objective (cont.)

The eCTD specification marked the start of a transition to electronic standards-based submissions. The eCTD format provides support for all application types including:

Starting on January 1, 2008, CDER withdrew previous eNDA and eANDA guidances, leaving eCTD as the only electronic submission format for CDER.

eCTD is the preferred format for submitting applications to CDER.

Five documents lying on a conference table on top of each other with the following titles:

Investigational New Drug Application 
New Drug Application 
Biologics License Application 
Abbreviated New Drug Application 
Drug Master File
USER INSTRUCTIONS:
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