May 1, 2017
23andMe green light is a shift for FDA
The April authorization for the genetic health test represents a dramatic change in FDA's longstanding policy on consumer-oriented genetic testing.
James R. Ravitz
Partner
Jamie was a partner in Wilson Sonsini's life sciences practice, representing manufacturers and distributors of products regulated by the FDA, including medical devices, drugs, biologics, food, cannabis, dietary supplements, and cosmetic products. Before joining the firm, Jamie led the FDA and health care life sciences practice at Arent Fox in Washington.
The Federal Drug Administration recently authorized the marketing of a medical device that permits ordinary Americans to gain valuable insight into our genetic predisposition for certain diseases, at home and without a prescription. But in the era of big data, common questions remain - can the data be trusted and what do we do with that information? Much of the FDA's concern with medical technology that provides information about genetics revolves around the latter question.
The Apr...
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