BLOOD SUBSTITUTE EFFICACY ENDPOINTS WILL EVOLVE THROUGH CLINICAL EXPERIENCE, FDA HEMATOLOGY HEAD SUGGESTS; RED CELL SUBSTITUTE WORKSHOP FINDS LITTLE CONSENSUS
Executive Summary
Blood substitute efficacy endpoints will evolve through clinical experience, FDA Center for Biologics Evaluation & Research Hematology Division Director Joseph Fratantoni, PhD, suggested at an agency cosponsored workshop on criteria for efficacy of red cell substitutes held at the National Institutes of Health Jan. 11.