U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Electronic Common Technical Document (eCTD): Overview and Submission
Currently submitting by paper? Select here.
Lesson 1: Introduction and Overview Lesson 2: Background on eCTD Standard Lesson 3: Submitting in eCTD Format Lesson 4: Transmitting Electronic Submissions to CDER  
Lesson 5: Submitting FDA Forms with Submissions Lesson 6: Validating eCTD Submissions Lesson 7: Submitting an eCTD Sample Lesson 8: Requesting a Pre-Assigned Application Number Lesson 9: Summary
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