Adhesion Reduction Endpoint Should Be Tied To Clinical Utility - FDA Panel
This article was originally published in The Gray Sheet
Executive Summary
Prevention or reduction of surgical adhesions may be used as a primary endpoint in clinical trials for anti-adhesion products, but it is up to the sponsor to demonstrate what the clinical benefit of adhesion prevention or reduction is in the study, FDA's Obstetrics and Gynecology Devices Panel concluded Jan. 25 in Gaithersburg, Maryland.