In an earlier post, I noted that the NDA is new application that is entirely separate from the IND. So, when you’re ready to file your NDA, this means that you must obtain a new eCTD application number. Fortunately, FDA makes this a very simple process that you can complete via email. There are three steps to the process:
- Establish that you can exchange secure emails with FDA
- Email email@example.com with your request for a new eCTD application number.
- You should receive your pre-assigned eCTD application number within 3 business days.
Further details can be found here, including information on how to set up secure email and what information to include in your request email.