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GENZYME SEPRAFILM APPROVABLE RECOMMENDATION LIMITED TO USES STUDIED IN TRIALS; FDA PANEL QUESTIONS CLINICAL BENEFIT OF ADHESION REDUCTION

This article was originally published in The Gray Sheet

Executive Summary

Genzyme is hoping that upcoming discussions with FDA will lead to approval of its Seprafilm bioresorbable membrane for a wider range of uses than endorsed by FDA's General and Plastic Surgery Devices Panel on March 25 at a meeting in Gaithersburg, Maryland.
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