FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus

Arleen Pinkos; Guillermo Arreaza-Rubin; William J Heetderks; Ilan Irony; Hylton V Joffe; Bruce Schneider; Charles L Zimliki

doi:10.1016/j.ddtec.2007.10.007

FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus

Drug Discov Today Technol. 2007 Autumn;4(1):25-8. doi: 10.1016/j.ddtec.2007.10.007.

Authors

Arleen Pinkos¹, Guillermo Arreaza-Rubin², William J Heetderks³, Ilan Irony⁴, Hylton V Joffe⁴, Bruce Schneider⁵, Charles L Zimliki⁶

Affiliations

¹ Center for Devices and Radiological Health, U.S. Food and Drug Administration, Office of Device Evaluation, 9200 Corporate Boulevard, HFZ-480, Rockville, MD 20850, United States. Electronic address:arleen.pinkos@fda.hhs.gov.
² National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, Division of Diabetes, Endocrinology and Metabolic Diseases, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
³ National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
⁴ Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Division of Metabolism and Endocrinology Products, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, United States.
⁵ Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Office of Cellular, Tissue, and Gene Therapies, 1401 Rockville Pike, Rockville, MD 20852, United States.
⁶ Center for Devices and Radiological Health, U.S. Food and Drug Administration, Office of Device Evaluation, 9200 Corporate Boulevard, HFZ-480, Rockville, MD 20850, United States.

PMID: 24980718
DOI: 10.1016/j.ddtec.2007.10.007

Abstract

One of the critical path initiatives of the Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective artificial pancreas for the treatment of diabetes mellitus. The FDA has established a multidisciplinary group of scientists and clinicians, in partnership with the National Institutes of Health (NIH), to address the clinical, scientific and regulatory challenges related to this unique medical product.: