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Food and Drug Administration

Blood Products Advisory Committee

August 16, 2007

SLIDES

Summary of May 10-11, 2007 Meeting of the DHHS Advisory Committee on Blood Safety and Availability, Jerry Holmberg, Ph.D. , Advisory Committee on Blood Safety and Availability (ppt) (htm)

Summary of April 25-26, 2007 FDA Workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing, Jennifer Scharpf, M.P.H., OBRR, FDA (ppt) (htm)

Summary of August 15, 2007 FDA Workshop on Licensure of Apheresis Blood Products, Lore Fields, DBA, OBRR, FDA (ppt) (htm)  )

Summary of January 29-30, 2007 WHO Meeting with WHO Collaborating Centres for Biological Standards and Standardization to Support the Development of WHO Biological Reference Preparations for Blood Safety-related in vitro Diagnostic Tests, Paul A. Mied, Ph.D., DETTD, OBRR, FDA (ppt) (htm)

Potency and Safety Standards for Plasma Derivatives, Mei-ying W. Yu, Ph.D., DH, OBRR, FDA (ppt) (htm)

Joint FDA/WHO Minimum Potency Standards for Certain Blood Grouping Reagents,  Sheryl Kochman, DBA, OBRR, FDA (ppt) (htm)

Topic I: Response to the Office of Blood Research and Review Office Level Site Visit for Research, July 22, 2005 – Introduction, Kathryn Carbone, M.D., OD, CBER, FDA (ppt) (htm)

Office Response, CD Atreya, Ph.D., OBRR, FDA (ppt) (htm)

Topic II:  Measles Antibody Levels in U.S. Immune Globulin Products, Introduction, Basil Golding, M.D., DH, OBRR, FDA (ppt) (htm) )

Current Epidemiology of Measles in the U.S., Jane Seward, M.B.B.S., M.P.H., CDC (ppt) (htm)

Measles Infections and Estimated Protective Titers in Primary Immune Deficiency Diseases and Potential Reemergence of Epidemic Measles in Vaccinated Individuals, William Moss, M.D., M.P.H.,  Johns Hopkins Bloomberg School of Public Health (ppt) (htm)

Measles Antibody Titers in Plasma Donors, Toby Simon, M.D., CSL Behring (ppt) (htm)

Measles Antibody Levels over Time in Licensed Immune Globulin Products and Patients with Primary Immune Deficiency Diseases, Don Baker, Ph.D., Baxter Healthcare Corporation (ppt) (htm)

Measles Antibody Levels over Time in Licensed Immune Globulin Products and Patients with Primary Immune Deficiency Diseases, Othmar Zenker, M.D., CSL Behring (ppt) (htm)

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