Lifecore Biomedical puts FDA dispute mechanism to the test
This article was originally published in Clinica
Executive Summary
Lifecore Biomedical will become the first company to test the effectiveness of the FDA's medical devices dispute resolution panel. The Chaska, Minnesota company will go before the panel on June 4 in a bid to overturn the agency's refusal to grant a premarket approval application for its ferric hyaluronate product, Gynecare Intergel, an adhesion protection solution designed to reduce internal scarring after gynaecology.