1. Emea Biotechnology Working Party Points to Consider on Human Somatic Cell Therapy, CPMP/BWP/41450/98 draft.
2. Food, Drug, and Cosmetic Act (as amended by the FDA Modernization Act of 1997).
3. Application of current statutory authorities to human somatic cell therapy products and gene therapy products;U.S. Food and Drug Administration Notice,1993
4. Human tissue intended for transplantation;U.S. Food and Drug Administration Notice of Interim Rule,1993
5. Products comprised of living autologous cells manipulated ex vivo and intended for implantation for structural repair or reconstruction;U.S. Food and Drug Administration Notice of Public Hearing,1995