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FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus. 2007
Arleen Pinkos, and
Guillermo Arreaza-Rubin, and
William J Heetderks, and
Ilan Irony, and
Hylton V Joffe, and
Bruce Schneider, and
Charles L Zimliki
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.
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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