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

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

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

Arleen Pinkos et al. Drug Discov Today Technol. 2007 Autumn.

. 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.:

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

Affiliations

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

Authors

Affiliations

Abstract

LinkOut - more resources

Full Text Sources