FDA

A “Bio Buzz” Interview with Anne Wojcicki

June 25, 2014
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...
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Update On The Regulatory Review Process With The FDA

June 20, 2014
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....
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More From SXSW #AskAnne

March 18, 2014
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...
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23andMe Looks Back One More Time

February 03, 2014
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...
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This Year’s Top Ten Genetic Findings

December 27, 2013
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...
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23andMe Provides An Update Regarding FDA’s Review

December 05, 2013
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...
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An Update Regarding The FDA’s Letter to 23andMe

November 26, 2013
23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives. It...
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23andMe Statement Regarding FDA Warning Letter

November 25, 2013
We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our...
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New Standards Regulating Gluten Labeling

August 13, 2013
New rules issued by the US Food and Drug Administration earlier this month mean we may finally know what it means when a label on food we buy says “Gluten-Free.”...
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Blood Thinners and the Genetics Behind Drug Response

October 02, 2012
A study in the journal Lancet regarding a new blood thinning drug brings to mind the difficulty doctors and patients have in using anticoagulants to prevent clots that could otherwise...
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