Recombinant and Human Plasma-derived Factor VIII Products
Recommendation
12-14 December 2023
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products
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This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor VIII products is made for use in treatment and prevention of bleeding in patients with haemophilia A. The guidance 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.
For further details please see the "Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products".
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