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.

 

Both comments and pings are currently closed.

One Response to “Requesting a Pre-Assigned Application Number”

  1. [...] follow up in future posts with more information about how to request a new application number and about how to cross reference between [...]