Clinical investigation of recombinant and human plasma-derived factor VIII products - Scientific guideline

This document covers clinical investigations to be conducted pre- and post-marketing authorisation for recombinant or human plasma-derived factor VIII products that are intended to use in the treatment and prevention of bleeding in patients with haemophilia A.

Keywords: Recombinant factor VIII, plasma-derived factor VIII, efficacy, safety, immunogenicity, inhibitor, potency assays

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