FDA Warning Letter to 23andMe

Re:FDA Warning Letter to 23andMe by dragonwriter on Monday November 25, 2013 @01:28PM (#6795844)

> It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing.

I don't think that's accurate either. I think that the FDA views that 23andMe must do one of the following:

1) Provide necessary evidence to support their current marketing claims, or

2) Change the way they are marketing their product, or

3) Cease marketing their product altogether.

I don't see that the FDA necessary has a strong preference as to which manner of complying with the law 23andMe takes.

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Re:FDA Warning Letter to 23andMe by tptacek on Monday November 25, 2013 @01:33PM (#6795889)

Sorry, you're right, I was being imprecise. Obviously, I think (2) is the only viable option here; 23AM doesn't appear to be set up for clinical genomics. But that bias was built into my comment implicitly, not stated directly like it should have been.

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