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

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

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RAPS.org
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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.