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FDA - Pre-Assigned NDA, IND, BLA and DMF number requests through the CDER NextGen Portal from the 19th of August

Starting August 19, 2019, pre-assigned NDA, IND, BLA and DMF number requests can be submitted via the CDER NextGen Portal. The FDA made this option available for abbreviated new drug applications (ANDAs) in June 2019.

 What are the benefits of submitting requests via the Portal?

·    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 requests.

·    Historical record: The requestor can view all requests at any time. The Portal organizes all your requests based on status (e.g. pending, closed).

This is an exciting step in providing a better and more efficient way of submitting a request for Pre-Assignment Application number. Look out for more information as we get closer to making this feature available. If you have any questions, please email edmsupport@fda.hhs.gov .

Ian Abernethy