Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

Has 23andMe told their side of the story yet? The FDA's press release made it sound like 23andMe was very negligent, but there has to be more to it than that. I can't imagine a company just ignoring the FDA's requests.


They posted this to Facebook:

Hi everyone, Many of you have seen and been asking about this morning's news.

Here's the statement we've issued to the media: "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 address their concerns."

We'll continue to keep you updated here as we know more. Thanks for all the messages of support!

https://www.facebook.com/23andMe/posts/10152374363517802




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: