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FDA May Use Panels More Often To Evaluate Emergency Research Protocols

Executive Summary

FDA is questioning whether protocols for emergency research conducted without individual informed consent should be subjected to more public input

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Hemopure advisory committee

FDA's Blood Products Advisory Committee will meet Dec. 14 to review Biopure's experimental blood product Hemopure [hemoglobin glutamer-250(bovine)] for out-of-hospital treatment of hermorrhagic shock, including the Navy's proposed RESUS clinical trial of the oxygen therapeutic. A closed-door meeting of the panel to discuss Hemopure was scheduled last July but was cancelled due to concerns about the need for more public input (1"The Pink Sheet" Sept. 11, 2006, p. 24). The meeting will be held from 8 a.m. to 6 p.m. at the Crown Plaza in Silver Spring, MD...

Hemopure advisory committee

FDA's Blood Products Advisory Committee will meet Dec. 14 to review Biopure's experimental blood product Hemopure [hemoglobin glutamer-250(bovine)] for out-of-hospital treatment of hermorrhagic shock, including the Navy's proposed RESUS clinical trial of the oxygen therapeutic. A closed-door meeting of the panel to discuss Hemopure was scheduled last July but was cancelled due to concerns about the need for more public input (1"The Pink Sheet" Sept. 11, 2006, p. 24). The meeting will be held from 8 a.m. to 6 p.m. at the Crown Plaza in Silver Spring, MD...

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