美国食品药品监督管理局在开发用于治疗糖尿病的人工胰腺方面所发挥的积极作用。
FDA's proactive role in the development of an artificial pancreas for the treatment of diabetes mellitus.
作者信息
Pinkos Arleen, Arreaza-Rubin Guillermo, Heetderks William J, Irony Ilan, Joffe Hylton V, Schneider Bruce, Zimliki Charles L
机构信息
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.
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.
出版信息
Drug Discov Today Technol. 2007 Autumn;4(1):25-8. doi: 10.1016/j.ddtec.2007.10.007.
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.:
美国食品药品监督管理局（FDA）的关键路径计划之一是加速开发并提供用于治疗糖尿病的安全有效的人工胰腺。FDA与美国国立卫生研究院（NIH）合作，组建了一个由科学家和临床医生组成的多学科团队，以应对与这种独特医疗产品相关的临床、科学和监管挑战。
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