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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IRS Ruling On Deductibility Of 23andMe Genetic Test Will Increase Patient Access, Firm Says
A new ruling by the US Internal Revenue Service allowing purchases of 23andMe Inc.’s genetic health test kit with tax-deductible flexible spending and health savings accounts should increase access to the product, the firm said on 23 July.
Scott Gottlieb Calls It Quits After An Active Tenure At US FDA
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.
DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says
The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.