PharmaNetics
This article was originally published in The Gray Sheet
Executive Summary
Humanitarian device exemption (HDE) application is filed with FDA for the ECT Ecarin clotting time test card for monitoring the anticoagulant effect of Refludan, Hoechst Marion Roussel's thrombin inhibitor drug. The ECT test card is currently being used under the agency's more limited "compassionate use" exemption
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