How to Apply for a Pre-Assigned Application Number

If you're ready to start submitting eCTD applications at the Pre-IND or IND stage -- or even getting ready to submit your NDA or BLA, you'll need an application number to submit electronically. Today we'll talk about the different ways to apply for a pre-assigned application number.

What is a Pre-Assigned Application Number?

The application number is a six-digit code that identifies your application with FDA. You'll use it throughout the lifecycle of your application. In the case of an IND, you'll use it for your first meeting request all the way to your initial application and beyond to safety reporting and lifecycle submissions. Similarly, for marketing applications like NDAs or BLAs, you'll use it for any pre-NDA/BLA submissions, for your initial application, and for further supplement, ad/promo, other types of submissions.

How to Apply for a Pre-Assigned Application Number from CDER

If you're planning to submit to the Center for Drug Evaluation and Research (CDER), there are two methods of applying for a pre-assigned application number: through CDER's NextGen Portal, or via secure email.

Applying for a Pre-Assigned Application Number via the NextGen Portal

First things first, you'll need to apply for a NextGen Portal account. You can go to https://edm.fda.gov and sign up at that link.

Once you've created your account, log in and scroll down to the Pre-Assignment Link.

From there, click on New Request.

Next, select the type of submission.

You'll then be asked for the details of your planned application.

Once you've provided this information, you can submit your request. You should receive an email confirmation for both your request and for further updates; the information can also be found in the portal.

Applying for a Pre-Assigned Application Number via Secure Email

If you do not have and do not want to apply for the CDER NextGen portal, you can apply for a pre-assigned application number via secure email. The instructions to do this are available on FDA's website here.

How to Apply for a Pre-Assigned Application Number from CBER

If you're applying for a pre-assigned application number from CBER, you'll follow a similar process to CDER's email request. Ensuring you have secure email set up ahead of this process is imperative. (You can refer to FDA Guidance: Best Practices for Communication Between IND Sponsors and FDA During Drug Development and CBER’s SOPP 8119, Use of Email for Regulatory Communications.)

The process is outlined in SOPP 8117, Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format, but here are the basics:

• Request your tracking number from CBERRIB@fda.hhs.gov no earlier than 4 weeks in advance of the anticipated submission date.

• Include in your request the sponsor/applicant name and address, primary point of contact name and phone number, the biologic product name, indication, and the anticipated submission date.

• You should receive your tracking number within 2 business days of your request.

Conclusion

Applying for your application number is an exciting milestone in your drug development journey. Understanding how to accomplish this task and planning for it ahead of time ensures your eCTD submission publishing process gets started smoothly.

If you need help during the Pre-IND submission process or publishing your initial application, The Sugar Water Operations Team can help. With 20 years of experience in eCTD publishing, we can make sure you have the technical expertise you need to get your submissions successfully through Electronic Submissions Gateway and into FDA's hands. Contact us today to discuss how we can help you meet your milestones.

References

• CDER: Requesting a Pre-Assigned Application Number

• SOPP 8117, Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format

• Best Practices for Communication Between IND Sponsors and FDA During Drug Development

• CBER’s SOPP 8119, Use of Email for Regulatory Communications