Fibrin sealant time to hemostasis recommended by FDA as endpoint for BLA approval.
This article was originally published in The Gray Sheet
Executive Summary
FIBRIN SEALANT TIME TO HEMOSTASIS RECOMMENDED AS PRIMARY CLINICAL ENDPOINT in an FDA Center for Biologics Evaluation and Research draft guidance, "Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use," released Jan. 26.