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
Submitting in eCTD Format
MenuGlossaryHelpFAQsResourcesFDA/DRUGSCDERLearn
Published Guidance and Specifications Documents

Review the following published guidance and specification documents for background information and for importance:

Note: Click the Resources tab to view the list of all published guidance and specifications documents.
Graphic of several documents. Document of Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format Document of Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety Web image of Clarification for Question #10 of ICH M4 Document of eCTD Backbone File Specification for Module 1 Document of eCTD Backbone File Specification for Modules 2 through 5.3.2.2
USER INSTRUCTIONS:
Click NEXT to continue.
Page 5 of 12
Back Button
Next Button