Transmissible Spongiform Encephalopathies Advisory Committee > October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document

October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document
October 28-29, 2010

REFERENCES

Topic I: A 2010 Update of the FDA Risk Assessment for P otential Exposure to the Infectious Agent of Variant Creutzfeldt-Jakob Disease (vCJD) in US-licensed Plasma-Derived Factor VIII (pdFVIII)

1.C larke P and Ghani AC. Projections of the future course of the primary vCJD epidemic in the UK: inclusion of subclinical infection and the possibility of wider genetic susceptibility J. R. Soc. Interface 2005, 2:19-31.
2.Hilton DA, Ghani AC, Conyers L, Edwards P, McCardle L, Ritchie D, Penney M, Hegazy D, Ironside JW. Prevalence of lymphoreticular prion protein accumulation in UK tissue samples. J Pathol. 2004, 203:733-9.


Topic II: Proposed Revisions to the Labeling Recommendations to Reflect Potential Risk of vCJD in Plasma Derivatives

1.Brown, P., Cervenakova, L., McShane L.M., Barber, P., Rubenstein, R., and Drohan, W.N. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzefeldt-Jakob disease in humans. Transfusion 39: 1169-78, 1999.
2.Brown, P., Rohwer, R.G., Dunstan, B.C., MacAuley, C., Gajdusek, D.C., Drohan, W.N. The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy. Transfusion 38: 810-6, 1998.
3.Dorsey, K., Zou, S., Schonberger, L.B., Sullivan, M., Kessler, D., Notari IV, E., Fang, C., and Dodd, R.Y. Lack of evidence of transmission of Creutzfeldt-Jakob diseases in a US surveillance study. Transfusion 49: 977-84, 2009.
4.FDA Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, December 2009.
5.FDA Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products, May 2010.
6.Foster, P.R. Removal of TSE agents from blood products. Vox Sang 87 Suppl 2: 7-10, 2004.
7.Gregori, L., Maring, J.-A, MacAuley, C., Dunston, B., Rentsch, M., Kempf, C., and Rohwer, R.G. Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals 32: 1-10, 2004.
8.Holman, R.C., Belay, E.D., Christensen, K.Y., Maddox, R.A., Minino, A.M., Folkema, A.M., Haberling, D.L., Hammett, R.A., Kochanek, K.D., Sejvar, J.S., Schonberger, L.B. Human prion diseases in the United States. PLoS ONE 5(1): e8521, 2010.

Transmissible Spongiform Encephalopathies Advisory Committee > October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting References Document


October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting 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)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231018.pdf



October 28-29, 2010: Transmissible Spongiform Encephalopathies Advisory Committee Meeting Document: APPENDIX A Supplemental technical information for the FDA Risk Assessment (PDF - 307KB)
Posted: 10/26/2010
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/TransmissibleSpongiformEncephalopathiesAdvisoryCommittee/UCM231019.pdf