There May Be More to the FDA/23andMe Story Than Meets the Eye

December 12, 2013 6:35 PM

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Consumers and life science startup companies alike are reacting strongly to the recent decision by the FDA to restrict the genetic testing company, 23andMe, from marketing its genetic testing service. In our day-to-day work, we are frequently approached with a gamut of regulatory questions from both large and small life science companies navigating the intersection of the changing regulatory and technology environments like this. This convergence is the most difficult part of blending creativity with business practicality—the place we like to dive in headfirst.

With the recent increase in remote medical monitoring activities and devices and the increasing importance of emerging genetic information technologies, it is unlikely that this will be the last that we hear of regulation and innovation not being fully aligned. So, naturally, the 23andMe story is ve...

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