FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.
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FDA has released guidance specifying the Data Universal Numbering System (DUNS) as the unique facility identifier system for registration of domestic and foreign drug establishments. DUNS is assigned and managed by Dun and Bradstreet. FDA has been using the DUNS number as a registration number for drug establishments since the implementation of electronic drug registration and listing.
The deal gives Fresenius options on biosimilars spanning monoclonal and bispecific antibodies, ADCs, and fusion proteins, starting with polatuzumab vedotin and teprotumumab, and could expand its portfolio from 29 to 66 molecules.