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
Module Introduction/Objectives

Welcome to the Submitting in eCTD Format module. In this module, you will learn how to submit in eCTD format and utilize the eCTD specifications and guidance.

Review the graphic to the right that shows the objectives for this module.

Specialized software is needed in order to compile documents into eCTD format for submission. This usually involves software that allows both publishing and viewing of the eCTD submission. Some companies choose to outsource this process.

While the FDA does not endorse particular software or outsourcing solutions, it is possible to easily identify firms that provide eCTD products and services by doing a simple Web search on "eCTD publishing."

A laptop with the word Objectives displayed on the screen followed by: Identify how to submit an eCTD format. Identify how to access and use the eCTD specifications and guidance.
USER INSTRUCTIONS:
Click NEXT to continue.
Page 2 of 12
Back Button
Next Button