Why the New FDA Glucose Meter POCT Guidance Is Disappointing
نویسندگان
چکیده
منابع مشابه
Informal guidance and the FDA.
This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of policymaking, as opposed to more formalized procedures like notice-and-comment rulemaking or case-specific adjudication. Using major developments in administrative law and modifi...
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Corresponding autor: Brad S. Karon Department of Laboratory Medicine and Pathology Mayo Clinic 200 First Street SW Rochester, MN 55905 Phone: 507-538-4921 Fax: 507-538-7060 E-mail: [email protected] Disclosures: No financial support or conflicts of interest to disclose.
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Approximately 18 million people suffer from diabetes mellitus, also known as diabetes, only in the United States which is 5% of the total population. It is the seventh leading cause of death. By 2020, the cost associated with diabetic treatment is expected to rise as high as $192 billion (Freer, March 2011). There is no cure for diabetic till date. Measuring glucose level in a diabetic patient ...
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ژورنال
عنوان ژورنال: Journal of Diabetes Science and Technology
سال: 2016
ISSN: 1932-2968,1932-2968
DOI: 10.1177/1932296816682763