Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy.
The Food and Drug Administration has seen a significant increase in investigational new drug (IND) applications for the use of allogeneic islets of Langerhans to treat type 1 diabetes mellitus. The current regulatory framework for clinical use of allogeneic islets of Langerhans is described. In addition, expectations and considerations for information to be included in the manufacturing, preclinical, and clinical sections of an IND for allogeneic islets of Langerhans to treat type 1 diabetes mellitus are discussed.
Weber
Darin J
DJ
Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA. weberd@cber.fda.gov.
McFarland
Richard D
RD
Irony
Ilan
I
D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D016381:Islets of Langerhans Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards; D014184:Transplantation, Homologous; D014481:United States