QUOTED. April 17, 2018. Scott Gottlieb.
Executive Summary
US FDA has released three final guidances aimed at making development of new cancer therapeutics a more efficient and less costly process. Check out what FDA Commissioner Scott Gottlieb said about them here.
"The policy approach outlined in these new guidance documents will provide test developers with a more efficient path to market. These new policies will improve the FDA’s ability to protect public health by ensuring these tests provide accurate and meaningful results, while at the same time speeding patient access to NGS assays by lowering barriers to innovation." –Scott Gottlieb, commissioner, US FDA
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