(1) Department of Health and Human Services Food and Drug Administration 21 CFR Part 316 (Docket No. 85N-0483), RIN 0905-AB55 Orphan Drug regulations, Subparte C disponible en www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesCon... yforOrphanProductDesignation/ucm135122.htm
(2) Wilate(R) Approved Complete Prescribing Information, Diciembre de 2009.
(3) Ibid.
(4) Note for guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses CPMP/BWP/268/95 Febrero de 1996.
(5) Note for guidance on plasma-derived products CPMP/BWP/269/95, rev.2. Julio de 1998.
(6) Farrugia A . Guide for the assessment of clotting factor concentrates for the treatment of Hemophilia. 2003, WFH.
(7) Centers for Disease Control and Prevention. Bleeding disorders. Disponible en www.cdc.gov/ncbddd/hbd/hemophilia.htm. Acceso el 22 de noviembre de 2009.
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Olaf Walter, dóctor, PhD, responsable de la Unidad Empresarial Internacional de Coagulación, olaf.walter@octapharma.ch, +41-55-4512-115
