US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests
Formalizing an approach applied to oversight of 23AndMe's direct-to-consumer genetic health risk tests, US FDA Nov. 6 said it plans to allow DTC testing services to be exempted from pre-market review after each individual maker of such an offering comes to the agency for a one-time review to ensure it meets FDA requirements.
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The commissioner says he will step down next month, leaving a legacy of active policy development, but also a lot of initiatives and pilot projects that are in the middle of being implemented.
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