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Regulatory Focus™ > News Articles > 2019 > 8 > Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

Posted 19 August 2019 | By  

Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file (DMF), via the Center for Drug Evaluation and Research (CDER)’s NextGen Portal.
 
The pre-assigned number requests were previously made via email. But now the firms submitting such applications can use the portal, which is a website for users to report information to FDA and which uses multi-factor authentication to ensure the data remains secure. The portal was initially only available for abbreviated new drug applications in June.
 
“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,” FDA says.
 
CDER NextGen Portal
 
Requesting a Pre-Assigned Application number

 

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Tags: BLA, DMF, IND, NDA