Food and Drug Administration

Center for Biologics Evaluation and Research


Meeting #36, October 9-10, 2003




1)      FDA “Dear Colleague” Letter (


2)      Shapiro, A, Lakey, J, Ryan, E. Korbutt, G., Toth, E., Warnock, G., Kneteman, N., Rajotte, R.  Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen.  N Engl J Med 2000; 343:230-8.


3)      White, S., James, R., Swift, S., Kimber, R., Nicholson, M.  Human islet cell transplantation—future prospects.  Diabetic Medicine 2001; 18:78-103.


4)      Weber, D., McFarland, R., Irony, I.  Selected Food and Drug Administration Review Issues for Regulation of Allogeneic Islets of Langerhans as Somatic Cell Therapy.  Transplantation 2002; 74:1816-1820.


5)      Ryan, E, Lakey, J., Paty, B., Imes, S., Korbutt, G., Kneteman, N., Bigam, D., Rajotte, R., Shapiro, A.  Successful islet transplantation; continued insulin reserve provides long-term glycemic control 2002. Diabetes; 51:2148-2157.