FDA Advisory Panel Recommends More Regulation Of DTC Genetic Tests
This article was originally published in The Gray Sheet
Executive SummaryAn FDA advisory panel March 8 and 9 pressed CDRH to bring more physician oversight and regulation into direct-to-consumer genetic testing.
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The seller of a $99 direct-to-consumer genetic test service is running ads with actors discussing the values of learning one’s personal DNA profile. But the firm’s continued marketing of the testing services and now its high-profile ads may raise questions about the regulatory status of its offerings.