March 18-19, 2014 from 8:30 a.m. to 4:30 p.m. and 9:00a.m. to 11:30a.m., Respectively : Blood Products Advisory Committee.
March 18-19, 2014 from 8:30 a.m. to 4:30 p.m. and 9:00a.m. to 11:30a.m., Respectively : Blood Products Advisory Committee
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center – The great Room (rm. 1503) Room 1066.
Silver Spring, MD 20993-0002
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
You can access the current roster of the Blood Products Advisory Committee HERE.
On March 18, 2014, the Blood Products Advisory Committee will meet in open session to discuss the evaluation of the safety and effectiveness of the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited (An Immucor Company). In the afternoon, the committee will hear update presentations on the following topics: (1) Report from the Presidential Commission for the Study of Bioethical Issues on the ethical implications of incidental findings in clinical, research, and direct-to-consumer contexts; (2) summary of the January 28-29, 2014, FDA public workshop on immune globulin-associated hemolysis; and (3) a summary of the December 4-5, 2013, HHS Advisory Committee on Blood and Tissue Safety and Availability.
On the morning of March 19, 2014, the committee will meet in open session to hear presentations on the research programs of the Laboratory Hemostasis, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
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