Document Detail


Personalized medicine in diabetes: regulatory considerations.
MedLine Citation:
PMID:  20144322     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Personalized medicine has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The U.S. Food and Drug Administration (FDA) is interested in promoting personalized medicine, whenever appropriate, to protect and promote the public health. The ability to better diagnose, screen, and manage patients with diabetes in order to individualize care should lead to better health outcomes and a large benefit to public health. This article describes FDA regulatory considerations for devices intended for use as personalized medicine tools for the diagnosis and treatment of patients with diabetes.
Authors:
Courtney C Harper
Publication Detail:
Type:  Journal Article     Date:  2009-07-01
Journal Detail:
Title:  Journal of diabetes science and technology     Volume:  3     ISSN:  1932-2968     ISO Abbreviation:  J Diabetes Sci Technol     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2010-02-10     Completed Date:  2010-06-02     Revised Date:  2011-03-11    
Medline Journal Info:
Nlm Unique ID:  101306166     Medline TA:  J Diabetes Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  739-42     Citation Subset:  IM    
Copyright Information:
Copyright 2009 Diabetes Technology Society.
Affiliation:
Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland 20850, USA. courtney.harper@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Diabetes Mellitus / therapy*
Humans
Individualized Medicine*
Public Health / legislation & jurisprudence*
United States
United States Food and Drug Administration / legislation & jurisprudence*
Validation Studies as Topic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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