title: FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus.
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.:
authors: 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.
authors: Arleen
authors: A
authors: Pinkos
authors: 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.
authors: Guillermo
authors: G
authors: Arreaza-Rubin
authors: National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Bethesda, MD 20892, United States.
authors: William J
authors: WJ
authors: Heetderks
authors: 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.
authors: Ilan
authors: I
authors: Irony
authors: 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.
authors: Hylton V
authors: HV
authors: Joffe
authors: 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.
authors: Bruce
authors: B
authors: Schneider
authors: 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.
authors: Charles L
authors: CL
authors: Zimliki