Details

Autor(en) / Beteiligte

• Weber, Darin J
• McFarland, Richard D
• Irony, Ilan

Titel

Selected Food and Drug Administration review issues for regulation of allogeneic islets of langerhans as somatic cell therapy

Ist Teil von

• Transplantation, 2002-12, Vol.74 (12), p.1816-1820

Ort / Verlag

United States

Erscheinungsjahr

2002

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.