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
Transitioning to eCTD (From Paper or Non-eCTD Format)
Transitioning to eCTD
So far we have learned that resubmission of materials when transitioning to eCTD is generally not required. What else should we keep in mind about transitioning to eCTD?