EMEA: 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 plasma-derived factor IX products is made for use in treatment and prevention of bleeding in patients with haemophilia B. The guideline covers clinical investigations to be conducted pre- and post-marketing authorisation. The guideline is also provided for authorised products where a significant change in the manufacturing process has been made.
The source of the news: http://www.emea.europa.eu/pdfs/human/bpwg/14455209endraft.pdf