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Food and Drug Administration

Blood Products Advisory Committee

September 10-11, 2008


September 10, 2008


Summary of May 29-30, 2008 Meeting of the DHHS Advisory Committee on Blood Safety and Availability, Jerry A. Holmberg, Ph.D., Executive Secretary, Advisory Committee on Blood Safety and Availability (htm)


Topic I: Strategies to Enhance Bacterial Safety of 7 day Platelets for Transfusion

Introduction, Jaro Vostal, M.D., DH, OBRR, FDA (htm)

Issues in Detection of Bacterially Contaminated Platelet Products, Mark Brecher, M.D., University of North Carolina School of Medicine (pdf)

Bacterial Detection in Blood Components, Thomas Montag-Lessing, M.D., Paul Ehrlich Institute, Germany (pdf)

Redesign of PASSPORT Study for 7 Day Platelets, Louis Katz, M.D., Mississippi Valley Regional Blood Center (htm)

FDA Perspective on Re-introduction of 7 Day Platelets and Redesign of PASSPORT Study, Salim Haddad, M.D., DH, OBRR, FDA (htm)

Topic II: Iron Status in Blood Donors

Introduction, Les Holness, M.D., DBA, OBRR, FDA (htm)

Overview of Iron Metabolism and Impact of Iron Deficiency on Blood Donors, Gary Brittenham, M.D., Columbia University (htm)

Normal Values for Hemoglobin and Iron Stores, Sarah Cusick, Ph.D., Centers for Disease Control and Prevention (htm)

European Studies on Iron Replacement for Blood Donors, Karin Magnussen, M.D., Copenhagen University Hospital, Denmark (htm)

Management of Iron Status in Blood Donors, Barbara Bryant, M.D., University of Texas, Medical Branch, Galveston (htm)

A U.S. Blood Center Experience with Iron Replacement, Dan Waxman, M.D., Indiana Blood Center (htm)

REDS Studies on Iron Stores and Implications for Blood Donors, Ritchard Cable, M.D., American Red Cross (htm)

September 11, 2008


Summary of April 29-30, 2008 Workshop on Hemoglobin Based Oxygen Carriers: Current Status and Future Directions, Paul Buehler, Pharm.D., Ph.D., DH, OBRR, FDA and Toby Silverman, M.D., DH, OBRR, FDA (htm)

Summary of July 10-11, 2008 Blood Establishment Computer Software Conference, Sheryl Kochman, DBA, OBRR, FDA (htm)

Development of an Automated Blood Application Submission System, Elizabeth Callaghan, M.S., DBA, OBRR, FDA (htm)

“Draft Guidance for Industry: Requalification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitus B Core Antigen (Anti-HBc), Robin Biswas, M.D., DETTD, OBRR, FDA (htm)

Open Public Hearing Speakers

The Key to HBOC Safety, Bruce Pierce, Ph.D., Biopure (htm)

Summary: Blood Establishment Computer Software (BECS) Conference, Jim MacPherson, American Blood Centers (.htm)

Summary: 24 Hour Hold Workshop, Louis Katz, M.D., Mississippi Valley Blood Center (htm)

Statement – Donor Re-Entry When Repeatedly Reactive HBV Core Antibody Tests are Followed by Negative Nucleic Acid Tests, Dave Cavenaugh, Committee of Ten Thousand (2008-4379OPH2_4.htm)

Topic III: Options for Blood Donor Screening and Re-entry for Malaria

Introduction and Background, Sanjai Kumar, Ph.D., DETTD, OBRR, FDA (2008-4379S2_5.htm)

Evaluating Risk for Malaria Infection in United States Donors Deferred for Travel to Malaria-Endemic Areas, Bryan Spencer, M.P.H., American Red Cross (htm)

Donor Deferrels Due to Travel to Malarial Areas Among Members of America’s Blood Centers, Celso Bianco, M.D., America’s Blood Centers (htm)

Serologic Testing of Malaria Deferred Blood Donors: Ferreting Out the At-Risk Donors, David Leiby, Ph.D. (htm)

Risk analysis for Malaria Exposure in Blood Donors and It's Effect on Blood Safety and Availability, Hong Yang, Ph.D.and Mark Walderhaug, Ph.D., OBE, FDA (htm)

Open Public Hearing Speakers

Malaria Antibody Screening for Blood Safety, George Dawson, Abbott Laboratories (htm)

Malaria Antibody Testing, Colin Knox, Lab 21 Healthcare (htm)

ELISA Malaria Antibody Test – Specifications and Experiences in Europe, Patrick Jacquier, M.D., Bio-Rad, DiaMed (htm)

Statement – Approaches to Blood Donor Deferral for Travel to Malarious Areas, Steven Kleinman, M.D., AABB Transfusion Transmitted Diseases Committee (pdf)

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