FDA U-turn lets Lifecore enter US market
This article was originally published in Clinica
Executive Summary
Lifecore Biomedical's bid to overturn the US FDA's refusal to approve its adhesion prevention solution has paid off. In an unprecedented decision announced last week, the agency's Medical Devices Dispute Resolution Panel (MDDRP) reversed the FDA's original verdict, giving Lifecore the green light to sell its product in the US.