1. 21CFR600.11(e)(3), 1998.
2. 21CFR600.11(e)(4), 1998.
3. Guidance for the submission of chemistry, manufacturing and controls information and establishment description for autologous somatic cell therapy products,1997
4. Guidance for the submission of chemistry, manufacturing and controls information and establishment description for autologous somatic cell therapy products,1997
5. 21CFR211.28(d), 1998.