23andMe Granted the First and Only FDA Authorization For DirecttoConsumer Pharmacogenetic Reports

23andMe Granted the First and Only FDA Authorization For Direct-to-Consumer Pharmacogenetic Reports

10:37 EDT 1 Nov 2018 | Speciality Pharma Journal

Mountain View, California – October 31, 2018 – In another first, the U.S. Food and Drug Administration (FDA) granted 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers’ genetics may influence the way they metabolize certain medications. This is the first authorization of a direct-to-consumer report on pharmacogenetics, and came through the FDA’s de novo classification process. …

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