Genzyme Carticel service on hold pending CDRH/CBER jurisdiction ruling.
This article was originally published in The Gray Sheet
GENZYME CARTICEL FDA JURISDICTION DECISION DUE BY JULY 5, the company says. FDA raised concerns with Genzyme's decision to launch Carticel March 31 without undergoing premarket review ("The Gray Sheet" April 3, I&W-3), prompting the company to halt the tissue repair service on April 28 and submit a request to FDA's ombusdman for a decision on which FDA center has regulatory jurisdiction over Carticel.
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