U.S. Food and Drug Administration
Protecting and Promoting Your Health
You have completed the Submitting in eCTD Format module. Let's take a minute to review the key points you have learned.
- Steps for submission of an eCTD include:
- Review the published guidance and specifications documents provided on the eCTD Web site, located under the Resources tab.
- Submit an eCTD sample prior to submitting the actual eCTD.
- Refer to the Comprehensive Table of Contents Headings and Hierarchy.
- Once you convert to eCTD, you must continue submitting in eCTD format.
- Only submit one electronic copy when you submit electronically.
- You can transition to eCTD submission at any time without prior consultation from your review division.
- Do not submit paper copies with eCTD submissions.
Click the MENU tab once to return to the Topic List for this lesson. Click it a second time to return to the Course Menu and select another module.
