Requesting a Pre-Assigned Application Number

Requesting for a Pre-Assigned eCTD NDA Number
Sample Email

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:

  1. Establish that you can exchange secure emails with FDA
  2. Email cderappnumrequest@fda.hhs.gov with your request for a new eCTD application number.
  3. 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.

 

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