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Expert Analysis

Personalized Medicine Providers, FDA Has Your Back

Law360, New York (November 8, 2013, 12:50 PM EST) -- According to the U.S. Food and Drug Administration, already more than 100 approved drugs contain information on genomic biomarkers, highlighting that personalized medicine is no longer a future fantasy, but it is present reality. Recent successes of co-development of personalized medicine including a drug and a companion diagnostic include Vemurafenib/BRAF V600E, approved in 2011 in 3.6 months through an expedited process; Crizotinib/ALK testing, approved in 2011 in 4.9 months with only 255 patients; and Tefinlar/Melkinist/THxID BRAF test approved in 2013....

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