The President's Precision Medicine Initiative calls for the increased use of diagnostic tools, such as genomic sequencing, to tailor treatments to specific patients. In December 2014, FDA released a discussion paper describing the challenges posed by the large amount of data produced by next-generation sequencing and the shortcomings of FDA's traditional regulatory model intended for single-disease detection. FDA will host a workshop on February 20, 2015, to receive public comments as it considers how to regulate these complex tools.
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