What exactly is a pre-assigned application number?

A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them to identify their application.

The FDA requires that you use this number any time you submit an eCTD application.

Before you request a pre-assigned eCTD application number, you need to apply for a secure email address with the FDA by contacting SecureEmail@fda.hhs.gov.

Click here for more information on how to obtain the pre-assigned application number.