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 authorisation. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.
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vroby (19 octobre 2024). EMA – Revision 2 of the Guideline on the clinical investigation of recombinant and human plasma-derived factor IX products. ELSIBI. Consulté le 18 mars 2025 à l’adresse https://doi.org/10.58079/12j9s