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Food and Drug Administration

Blood Products Advisory Committee

July 13, 2006


Committee Updates

Advisory Committee on Blood Safety and Availability, Strategic Plan, Jerry A. Holmberg, Ph.D., FDA (pdf) (ppt)

Workshop Summary FDA Workshop on Testing for Malarial Infections in Blood Donors, Sanjai Kumar, Ph.D., FDA (pdf) (ppt)

Site Visit Report, Review of Intramural Research, James Allen, MD, MPH (pdf) (ppt)

West Nile Virus Update, Maria Rios, Ph.D., FDA (pdf) (ppt)

Topic I.

Hepatitis B Immune Globulin (Human), Intravenous (Nabi-HB IV), Henrik Rasmussen, M.D., Ph.D., Nabi Biopharmaceuticals (pdf) (ppt)

Hepatitis B Immune Gobulin Intravenous (Human)(Nabi-HB Intravenous) to Prevent HBV Recurrence after Orthotopic Liver Transplantation (OLT) for Hepatitis B disease, Charles Maplethorpe, M.D., Ph.D., FDA (pdf) (ppt)

Statistical Review for the Nabi Biopharmaceuticals, Hepatitis B Immune Globulin Intravenous (HBIGIV), Jessica Kim, Ph.D., FDA (pdf) (ppt)

Questions for the Committee (pdf) (ppt)

Topic II.

FDA's Critical Path Research Initiative & Intro to the CBER Research Program, Kathryn M. Carbone, M.D., FDA (pdf) (ppt)

Office of Blood Research and Review: An Overview, C. D. Atreya, Ph.D., FDA (pdf) (ppt)

Division of Emerging and Transfusion Transmitted Diseases (DETTD), Overview, Hira Nakhasi, Ph.D., FDA (pdf) (ppt)

Review of Laboratory of Bacterial, Parasitic and Unconventional Agents Scientific Program

Site Visit by Ad Hoc Review Committee 25 May 2006, David M. Asher, M.D., FDA (pdf) (ppt)

Implications of TSE Infection and Disease for Maintaining the Safety of Biologics Source Materials, Pedro Piccardo, FDA (pdf) (ppt)

Genetically Modified Live Attentuated Parasites as Leishmania Vaccines, Evaluation of Safety and Efficacy, Hira Nakhasi, Ph.D., FDA (pdf) (ppt)

A. Discovery of New Genes related to Leishmania Pathogenesis and as Biomarkers of Attenuation Using a Genomic Microarray and B. Multiplex PCR Microarray Assay to Detect Pathogens in Blood, Site Visit Presentation, Robert Duncan, Ph.D. (pdf) (ppt)

Multiplex fluorescence-based PCR assay to detect pathogens in blood, A. Selvapandiyan, FDA (pdf) (ppt)

The Programmed Cell Death Pathway of Trypanosomatic Parasites, Alain Debrabant, PhD., FDA (pdf) (ppt)

Malaria Research Program at CBER, Studies to improve Blood Safety from the risk of transfusion-transmitted malaria, and malaria pathogenesis and control, Scientific Site Visit Review Summary, Sanjai Kumar, Ph.D., FDA (pdf) (ppt)

Open Public Hearing

Clinical Performance of HBIg in Preventing Recurrent HBV after Liver Transplantation, David K. Imagawa, M.D., Ph.D., University of California, Irvine Medical Center (pdf) (ppt)

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