October 28-29, 2010

On October 28, 2010 the Committee will discuss: (1) FDA’s risk assessment for potential exposure to the variant Creutzfeldt - Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII and (2) labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.

• Announcement
• A 2010 Update of the Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States (US) License From Plasma Collected in the US (PDF - 662KB)
• Document- APPENDIX A Supplemental technical information for the FDA Risk Assessment (PDF - 307KB)
• Draft Agenda
• Informational Issue Summary (PDF - 208KB)
• Labeling Issue Summary (PDF - 36KB)
• Presentations
• References Document
• Risk Assess Issue Summary (PDF - 171KB)
• Topic 3 Issue Summary (PDF - 33KB)
• Waivers for Conflict of Interest