Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
FDA Medical Devices Dispute Resolution Panel (MDDRP) will review the device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. The review, the first to occur since the MDDRP was mandated by the FDA Modernization Act of 1997, will likely take place in April. The company requested the review at the end of 2000 (1"The Gray Sheet" Jan. 1, 2001, In Brief)