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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

Jun 05, 2018

NEW YORK (GenomeWeb) – Late last week, the US Food and Drug Administration lifted some regulatory hurdles for makers of direct-to-consumer genetic health risk tests. After obtaining a first premarket authorization for a genetic health risk (GHR) test, manufacturers can now commercialize new tests without additional review.

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