ANTI-ADHESION DEVICE PREMARKET REQUIREMENTS RECONSIDERED BY FDA AFTER PANEL VOTES AGAINST APPROVAL OF GENZYME'S SEPRACOAT; AGENCY MAY HOLD PUBLIC FORUM
This article was originally published in The Gray Sheet
Executive Summary
Anti-adhesion device manufacturers' ability to rely on data from gynecological procedures to obtain approval for use of the products in abdominal surgery is being reconsidered by FDA after the agency's General and Plastic Surgery Devices Advisory Panel criticized Genzyme's premarket approval application for its Sepracoat anti-adhesion product. The six-member panel unanimously recommended against approval of Genzyme's premarket approval application due to insufficient efficacy data.