Every eCTD application – whether it’s an ANDA, IND, BLA, DMF, or NDA – requires an application number. In the days of paper submissions, FDA would assign an application number upon receipt, and then notify you after the fact. In the eCTD world, the application number is an essential metadata component that’s needed before you file the application. So, you must request a pre-assigned application number.
Fortunately, FDA makes this a very simple process that you can complete via email with both CDER and CBER.
Pre-Assigned Application Number for CDER
There are three main steps to the process:
- Establish that you can exchange secure emails with FDA.
- Email firstname.lastname@example.org with your request for a new eCTD application number.
- You should receive your Pre-Assigned Application Number within 3 business days.
Further details are available at this CDER webpage, including information on how to set up secure email and what information to include in your request email.
Pre-Assigned Application Number for CBER
CBER’s process is basically the same as CDER’s, although not as well defined. This Standard Operating Policy and Procedure lays out their internal procedure for issuing a pre-assigned application number. Essentially, you should email email@example.com with your request for an application number. The SOPP doesn’t specify what information is expected, but I’d recommend providing the same information CDER requests (as applicable).
[Editors Note: This post was originally published on 23 February 2011 and was updated with the most recent information from FDA.]