Lifecore Gynecare Intergel
This article was originally published in The Gray Sheet
Executive Summary
FDA agrees adhesion prevention solution is approvable for use in gynecological surgery as Center for Devices and Radiological Health Director David Feigal concurs with Sept. 6 Medical Devices Dispute Resolution Panel recommendation after less than a month of review. In its first-ever meeting, the MDDRP determined that the firm demonstrated a statistically significant treatment effect and that the device should be approved (1"The Gray Sheet" Sept. 10, 2001, p. 3). The Lifecore/FDA dispute focused on an initial November 2000 "not-approvable" determination by the agency. Final approval is anticipated pending "finalization of the labeling and the summary of safety and effectiveness," Lifecore says Oct. 5. A U.S. launch is slated for "early 2002"