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FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden? 24 February 2013 Personalized Medicine Bulletin The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine...
FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies 07 January 2013 Personalized Medicine Bulletin The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological...