FDA to Accept Pre-Assigned Application Number Requests Through CDER Portal
The FDA will soon allow drug sponsors to make requests for pre-assigned NDA, IND, BLA and DMF numbers through CDER’s online information reporting service.
Starting Aug. 19, applicants may submit requests for pre-assigned NDA, IND, BLA and DMF numbers through CDER’s NextGen Portal, allowing them to keep track of all information regarding requests in a single place. Sponsors will also receive an automatic confirmation following their filing of a request.
Requests can be viewed at any time and are organized according to their application status. In June, the agency began allowing pre-assigned ANDA number requests to be made through the online portal.