Drug Development

Regulatory status of U.S. Navy's proposed RESUS trauma trial updated

Published in Medical Letter on the CDC and FDA, January 8th, 2006

Biopure Corp. (BPUR) announced that representatives of the Navy, Biopure and the U.S. Food and Drug Administration (FDA) met to discuss the Navy's proposed RESUS clinical trial of Hemopure (hemoglobin glutamer - 250 (bovine)) for the out-of-hospital treatment of hemorrhagic shock in trauma patients.

As previously reported, the Navy's investigational new drug application (IND) to conduct this trauma trial is currently on hold at the FDA, primarily due to the agency's concerns about the risk-benefit profile in this patient population.

At the meeting, military and academic trauma experts from the Navy's RESUS advisory board addressed the FDA's concerns...

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Source: Medical Letter on the CDC and FDA (2006-01-08)

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