Category: FDA
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23andMe and the FDA clearance
As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medica…
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Genetic paternalists are very patronizing
An comment below on my post Genetic paternalism & the F.D.A.: I came across your inflamed post from March 9th and the more I read the more disappointed I became, especially when I read your comment “following twitter, it seems there may be a dis…
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DTC testing, mailing addresses, contact information, etc.
Chris, and others, have encouraged me to put up some contact information in regards to DTC testing and the . Here is what Chris has gathered…. The Center for Devices and Radiological Health (CDRH) is the division of the FDA that would be respon…
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Your genes, your rights – FDA’s Jeffrey Shuren misleading testimony under oath
Over the past few days I’ve been very disturbed…and angry. The reason is that I’ve been reading Misha Angrist and Dr. Daniel MacArthur. First, watch this video: In the very near future you may be forced to go through a “profess…