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FDA Outlines Plan for Expected $10M Under President’s Precision Medicine Plan
February 26, 2015The FDA is planning to put the $10 million the agency expects to receive under the President’s Precision Medicine Initiative to set up databases that can help inform its oversight of next-generation sequencing tests, and to establish the bioinformatics infrastructure to facilitate the curation and sharing of the information in those repositories, an agency official said today. “Reliable and accurate next-gen sequencing technologies have a very large promise to accelerate personalized or precision medicine,” Elizabeth Mansfield, deputy office director for personalized medicine at FDA’s Center for Devices and Radiological Health, said during a briefing. “We here at the FDA are seriously committed to optimizing our regulatory oversight of this technology, [and] to ensure that the tests developed using it are not only safe and effective but are available for patient use as soon as possible.”