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The President's Precision Medicine Initiative calls for the increased use of diagnostic tools, such as genomic sequencing, to tailor treatments to specific patients.
United StatesFood, Drugs, Healthcare, Life Sciences
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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