U.S. Food and Drug Administration
Protecting and Promoting Your Health
You have completed the Transitioning to eCTD (From Paper or Non-eCTD Format) module. Let's take a minute to review the key points you have learned.
- Resubmission of materials is generally unnecessary.
- The first eCTD submission should intentionally be coded as a first-level submission type in the us-regional.xml file.
- eCTD section 1.4.4 is used to cross reference information that was previously submitted.
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.