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March 18, 2014: Blood Products Advisory Committee Meeting Draft Agenda
FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
109th Meeting of the Blood Products Advisory Committee
Great Room, Building 31
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993
March 18-19, 2014
|8:30 a.m.||Call to Order and Opening Remarks
Introduction of Committee
|Christopher Stowell, Ph.D., M.D.
Acting Chair, BPAC
|Conflicts of Interest Statement||Bryan Emery, LCDR
Designated Federal Officer, BPAC
|Topic I: Evaluation of the Safety and Effectiveness of the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited|
|8:40 a.m.||Introduction||Orieji Illoh, M.D.
|9:00 a.m.||BioArray Presentations||Joanne Spadoro, Ph.D.|
|9:05 a.m.||Immucor PreciseTypeTM HEA Molecular BeadChip Test||Sukanta Banerjee, Ph.D.|
|10:00 a.m.||Red Cell Typing with the BioArray System||Connie Westhoff, Ph.D.|
|10:30 a.m.||Questions for Speakers|
|11:00 a.m.||FDA Review of Performance Studies||Annette Ragosta
|11:20 a.m.||FDA Statistical Analysis||Renee Rees, Ph.D.
|11:50 a.m.||FDA Resolution of Discrepancies and Conclusions||Annette Ragosta
|12:00 p.m.||Questions for Speakers|
|12:10 p.m.||Red Blood Cell Genotype Assays: Clinical Experience||Ellen Klapper, M.D.
Cedars Sinai Medical Center
|1:30 p.m.||Open Public Hearing|
|2:00 p.m.||Open Committee Discussion
Questions for the Committee
|3:30 p.m.||Presidential Commission for the Study of Bioethical Issues: Ethical Implications of Incidental Findings||Lisa Lee, Ph.D.
Presidential Commission for the Study of Bioethical Issues
|4:00 p.m.||Summary of January 28-29, 2014 FDA Public Workshop on Immune globulin-associated Hemolysis||Dorothy Scott, M.D.
|4:15 p.m.||Summary of Dec 4-5, 2013 HHS Advisory Committee on Blood and Tissue Safety and Availability||James Berger