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In Brief: Genzyme Carticel

This article was originally published in The Gray Sheet

Executive Summary

Genzyme Carticel: Firm's Tissue Repair division receives approvable letter from FDA indicating that its biologics license application for its cartilage replacement service is safe and effective for repair of clinically significant symptomatic focal defects of the femoral condyle (knee). Final approval requirements outlined by FDA in the June 19 letter, including manufacturing validation and finalization of product labeling and post-marketing study protocols, are expected to be addressed by late July or early August, Genzyme says. FDA's Orthopedic and Rehabilitation Devices Panel recommended at a March meeting that Genzyme's proposed postmarket study include a control group and randomization of both patients and physicians ("The Gray Sheet" March 10, p. 6)...
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