BioCentury
ARTICLE | Regulation

FDA delays end to regulatory stand-off

July 10, 1995 7:00 AM UTC

The FDA said it does not intend to regulate the Genzyme Tissue Repair division's Carticel cartilage cell service at this time, but has decided to hold a meeting Nov. 16 and 17 to consider the public health impact of such products and possible regulatory approaches to autologous cells manipulated ex vivo and intended for structural repair or reconstruction. Examples include cartilage, fat and skin.

The FDA meeting, to be held in Gaithersburg, Md., will not consider allogeneic and xenogeneic products. Gene therapy products, including autologous cell products intended for functional repair - such as pancreatic cells to produce insulin following pancreatectomy, autologous stem cells for replacement of muscle, and autologous lymphocytes activated to induce immune function - also will not be covered...