FDA Specifies Unique Facility Identifier System
FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.
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.
Source: FDA.gov
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
