Food and Drug Administration

Blood Products Advisory Committee

May 1, 2008

SLIDES

May 1, 2008

UPDATES and INFORMATIONAL PRESENTATIONS

Summary of August 22-23, 2007 and January 9-10, 2008 Meetings of the DHHS Advisory Committee on Blood Safety and Availability, Jerry A. Holmberg, Ph.D., Executive Secretary, Advisory Committee on Blood Safety and Availability (ppt) (htm)

2007 West Nile Virus Epidemiology and Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus in Whole Blood and Blood Components for Transmission, Maria Rios, Ph.D., DETTD, OBRR, FDA (ppt) (htm)

2007 West Nile Virus Epidemiology and Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus in Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps), Melissa A. Greenwald, M.D., CDR, USPHS, DHT, OCTGT, FDA (ppt) (htm)

Implementation of Blood Donor Screening for Infection with Trypanosoma cruzi (T. cruzi) and the Use of Serological Tests to Reduce the Risk of Transmission of T. cruzi Infection in Whole Blood and Blood Components for Transfusion, Robert Duncan, Ph.D., DETTD, OBRR, FDA (ppt) (htm)

Implementation of Blood Donor Screening for Infection with Trypanosoma cruzi (T. cruzi) and the Use of Serological Tests to Reduce the Risk of Transmission of T. cruzi Infection in Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps), Mellisa A. Greenwald, M.D., CDR, USPHS, DHT, OCTGT, FDA (ppt) (htm)

FDA’s Proposal to Lower the Minimum Recommended Lot Release Titer for Measles Antibodies in Immune Globulin Intravenous (Human)(IGIV) and Immune Globulin Subcutaneous (Human)(IGSC), Dorothy Scott, M.D., DH, OBRR, FDA (ppt) (htm)

Gambro/Fenwal Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post Marketing Study – 7 Day Platelets, Larry Dumont, MBA, Ph.D., Director of Cell Labeling Laboratory, Assistant Professor, Dartmouth Medical School (ppt) (htm)

Risk Analysis Related to PASSPORT Study, Louis Katz, M.D., Executive VP, Medical Affairs, Mississippi Valley Regional Blood Center (pdf)

FDA Perspective on PASSPORT Study, Salim Haddad, M.D., DH, OBRR, FDA (ppt) (htm)

CBER Blood Safety Team, Jonathan C. Goldsmith, M.D., Deputy Director, OBRR, FDA (ppt) (htm)

CBER Tissue Safety Team, Ruth Solomon, M.D., Supervisory Medical Officer, OCTGT, FDA (ppt) (htm)

 

Topic I: Biomedical Excellence for Safer Transfusion (BEST) Committee Report on Red Blood Cell Recovery Standards

FDA’s Approaches of Evaluation of Red Blood Cell Products, Ping He, M.D., Medical Officer, DH, OBRR, FDA (ppt) (htm)

Red Blood Cell Recovery and Survival: In Vivo Studies, Richard J. Davey, M.D., Professor of Pathology and Laboratory Medicine, Director, Transfusion Medicine, The Methodist Hospital, Houston, TX (ppt) (htm)

Age of Transfused Blood: Short-term Mortality and Long-term Survival after Cardiac Surgery, Mark Stafford-Smith, M.D., FRCPC, Professor of Anesthesiology, Duke University Medical Center (ppt) (htm)

Evaluation of Proposed FDA Criteria for the Evaluation of Radiolabeled Red Cell Recovery Trials, Larry Dumont, MBA, Ph.D., Director of Cell Labeling Laboratory, Assistant Professor, Dartmouth Medical School (ppt) (htm)

FDA’s Perspective on Statistical Methods in the Evaluation of Red Blood Cell Products (in vivo study), Jessica Kim, Ph.D., OBE, FDA (ppt) (htm)

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