The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more
2/25/2013 - CMS Diagnostic Tests FDA Labeling Laboratory Developed Tests Marketing Personalized Medicine Pharmaceutical
Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more
12/31/2012 - Genetic Markers Personalized Medicine Pharmaceutical
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