Tag: FDA

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: ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

An Update Regarding The FDA’s Letter to 23andMe

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 is absolutely critical that our consumers get high quality genetic data that they can trust.   We have worked extensively with our ...

Read more

23andMe Statement Regarding FDA Warning Letter

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 relationship with the FDA is extremely important to us and we are committed to fully engaging with them to ...

Read more

New Standards Regulating Gluten Labeling

Editor’s note: Pending an FDA decision, 23andMe no longer offers new customers access to health reports referred to in this post. Customers who purchased prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will not. Those customers will have ...

Read more

Blood Thinners and the Genetics Behind Drug Response

Editor’s note: Pending an FDA decision, 23andMe no longer offers new customers access to health reports referred to in this post. Customers who purchased prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will not. Those customers will have ...

Read more

Return to top