Lifecore Biomedical
This article was originally published in The Gray Sheet
Executive Summary
FDA Medical Devices Dispute Resolution Panel (MDDRP) review will be sought following device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. The firm had submitted an amendment to its March 1999 premarket approval application in June 2000, following a recommendation against approval from FDA's General and Plastic Surgery Devices Advisory Panel last January (1"The Gray Sheet" Jan. 17, 2000, p. 4). The MDDRP, mandated by the FDA Modernization Act of 1997, had its inaugural meeting Oct. 31, 2000 (2"The Gray Sheet" Nov. 6, 2000, In Brief)
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Lifecore Biomedical
FDA's Medical Device Dispute Resolution Panel will convene June 4 to review the device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. Comments or requests for time to make oral presentations should be submitted to ombudsman Les Weinstein by May 31. Background information and questions for the committee will be posted June 1 at http://www.fda.gov/cdrh/panelmtg.html. The review will be the first to occur since the MDDRP was mandated by the FDA Modernization Act of 1997 (1"The Gray Sheet" Jan. 1, 2001, In Brief)
Lifecore Biomedical
FDA's Medical Device Dispute Resolution Panel will convene June 4 to review the device center's "not approvable" determination for Lifecore's Gynecare Intergel ferric hyaluronate adhesion prevention solution. Comments or requests for time to make oral presentations should be submitted to ombudsman Les Weinstein by May 31. Background information and questions for the committee will be posted June 1 at http://www.fda.gov/cdrh/panelmtg.html. The review will be the first to occur since the MDDRP was mandated by the FDA Modernization Act of 1997 (1"The Gray Sheet" Jan. 1, 2001, In Brief)
Lifecore Biomedical
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)