FDA 483 - BIOGEN, INC - November 02, 2026

An FDA inspection of BIOGEN, INC in Cambridge, MA, identified two significant observations. The firm failed to adequately monitor the progress of an investigation under an IND, specifically regarding the trustworthiness and reliability of electronic records and audit trails. Additionally, the inspection found that the sponsor did not obtain sufficient financial information from clinical investigators, impacting the completeness and accuracy of required disclosure statements.