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

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

Home » 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.