Tag: FDA

A Note to Our Customers Regarding the FDA

By Anne Wojcicki Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US. This is also the first-time ...

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What The FDA Decision Means For 23andMe Customers

What does getting this marketing authorization mean for existing and future customers? As the first direct to consumer genetic test to complete the regulatory pathway, 23andMe’s Bloom Syndrome Carrier Status test was given marketing authorization through the de novo pathway. This is the first ...

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Drug Development’s Long And Winding Road

Before a medicine reaches pharmacy shelves, it goes through extensive and rigorous evaluation to prove it is safe and effective. We want to shed some light on a few of the steps involved in drug development and highlight how the work being done by 23andMe with the Inflammatory Bowel Disease Study can help ...

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23andMe In The News

Last week was a good one for research at 23andMe with two announcements that offer more examples of the power of our research model. First was the publication of a massive Parkinson’s disease study that our scientists worked on with a consortium of 50 other organizations that were lead by researchers at ...

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A “Bio Buzz” Interview with Anne Wojcicki

In San Diego at the annual Bio International Convention where she gave the keynote for a forum on personalized medicine, 23andMe CEO and Co-Founder Anne Wojcicki gave a short interview to Mike Huckman. Check it out here: ...

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Update On The Regulatory Review Process With The FDA

By Kathy Hibbs, Chief Legal and Regulatory Officer, 23andMe A few days ago the US Food and Drug Administration accepted for review 23andMe’s submission for a new 510 (k) application. This submission is for one health report, and is part of the FDA's regulatory review of our health product. Although the ...

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More From SXSW #AskAnne

We can’t tell you the breakout bands or best films from this year’s South By Southwest, but we can tell you that new ideas around digital health — including 23andMe’s use of big data to power research — drove a lot of the most interesting discussions on the interactive side of the festival. 23andMe’s CEO ...

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23andMe Looks Back One More Time

In honor of the Chinese New Year, we’re taking one last look at the genetic milestones of 2013. From a Supreme Court ruling on patenting genes, to Angelina Jolie’s bold revelations about her genetic risk for breast cancer, to the FDA ordering 23andMe to stop offering health results pending a regulatory ...

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This Year’s Top Ten Genetic Findings

Each year at this time 23andMe puts together a list of the most interesting genetic findings of 2013. We’re doing that again but with a twist. We want to include in our list a few things that aren’t findings or discoveries, but clearly these stories have had a huge impact on the field of genetics. The fact ...

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23andMe Provides An Update Regarding FDA’s Review

By Anne Wojcicki After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review processes. 23andMe has ...

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