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
Requesting a Pre-Assigned Application Number
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Module Introduction/Objective

Welcome to the Requesting a Pre-Assigned Application Number module. In this module, you will learn how to request a pre-assigned application number.

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

If you plan to submit your application to CDER in eCTD format, you will need to request a pre-assigned application number for all application types prior to submitting in eCTD format.

A laptop with the word Objective displayed on the screen followed by: Identify how to request a pre-assigned application number.
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