Autologous cell regulation

WASHINGTON - With the comment period winding toward a conclusion next month, FDA Commissioner David Kessler last week signaled that the agency will adopt a "flexible approach" to the regulation of autologous cell transfers.

The debate over regulation of autologous transfers was sparked by FDA's decision last April to regulate Genzyme Corp.'s Carticel process, which involves autologous transplantation of cartilage to treat knee injuries, under provisions it uses to regulate somatic cell transfers. The company protested and the agency decided to allow the procedure to be used without regulation pending resolution of wider issues related to autologous cell transfers...