Published in Blood Weekly, November 14th, 2002
The acceptance is based on the agency's determination that the BLA is adequate to permit a substantive and meaningful review.
On July 31, 2002, Biopure submitted an electronic BLA to the FDA seeking regulatory clearance to market Hemopure in the United States for the treatment of acute anemia in adult patients undergoing orthopedic surgery, and for eliminating or reducing the need for red blood cells in these patients. The application was based...
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