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Genzyme Tissue Repair (US) awaits FDA decision on Carticel classification

This article was originally published in Clinica

Executive Summary

Genzyme Tissue Repair (US) hopes to hear by July 5th whether its Carticel cartilage repair service will be classed as a device or cell therapy product. After the first Carticel treatment was performed, the FDA's Center for Biologics Evaluation and Research requested additional information to decide whether autologous cartilage cells constitute somatic cell therapy and would thus be regulated by the CBER. An FDA ombudsman is to decide whether the CBER or CDRH has jurisdiction over the product.

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