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Bio & Life Sciences Government

How the FDA’s Best Intentions Are Slowing the Genomics Revolution

Even as life-science companies pound out DNA sequencing improvements fast enough to make the computing industry look downright sedentary, the industry has been hindered in implementing its many advances so they can help patients in clinical settings. One major cause is the U.S. Food and Drug Administration, which has asserted it will regulate these next-generation sequencing tools—but has not yet decided what will be regulated, how evaluations will take place, or when this oversight might kick in. With widespread uncertainty about the regulatory environment, companies developing genomic products for clinical use have been in limbo, and the venture capitalists who haven’t fled the space are tightening their belts.   More