Submit Pre-Assigned New Drug Application (NDA), Investigational New Drug (IND), Biologic License Application (BLA) and Drug Master File (DMF) number requests through the CDER NextGen Portal

Submit Pre-Assigned New Drug Application (NDA), Investigational New Drug (IND), Biologic License Application (BLA) and Drug Master File (DMF) number requests through the CDER NextGen Portal

Beginning today, prospective applicants can submit pre-assigned number requests for four additional application types, NDA, IND, BLA and DMF, via the CDER NextGen Portal. The FDA made this option available for abbreviated new drug applications (ANDAs) in June 2019.

 If you already have a CDER NextGen Portal account, your account will now have the pre-assigned number request functionality. To create a new account, go to the CDER NextGen Portal, under the “Sign In” section, on the right of the screen, click “Sign Up” (next to “Don't have an account?”) and follow the instructions.

 For more login assistance, please go to: CDER NextGen Portal FAQs

 Benefits of using the Portal for pre-assigned number requests:

• Ease of Use: Requesting via the Portal is easy, and all information regarding your requests is in one place.
• Automated confirmation: You can log in, initiate a request, and receive an automated confirmation of your transaction.
• Historical record: The requestor can view all transactions at any time. The Portal organizes all your requests based on status (e.g. pending, closed).

For technical support, please email CDER Platform Support at edmsupport@fda.hhs.gov. 

For additional information on submitting pre-assigned application number requests, please visit the Requesting a Pre-Assigned Application number web page.