EMA – Revision 2 of the Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products

The EMA published its Second revision of the Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products. This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in the treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical investigations to be conducted pre- and post-marketing authori...