[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

Brian Manning Delaney listsb at infinitefaculty.org
Tue Nov 26 06:59:37 UTC 2013


El 2013-11-25 19:09, Dave Sill escribió:
> http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html
>
> 23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by
> Anne Wojcicki, was told by U.S. regulators to halt sales of its main
> product because it’s being sold without “marketing clearance or approval.”

[...]

Possible viral -- actually, mainstream media... -- falsehood warning. 
The FDA letter 
(http://www.fda.gov/.../WarningLetters/2013/ucm376296.htm) as I read it, 
only orders 23andMe to stop marketing the saliva collection kit. 
("23andMe must immediately discontinue marketing the PGS until such time 
as it receives FDA marketing authorization for the device.") Is 
marketing it (for a particular purpose) the same as /selling/ it 
(without mentioning said, or any, purpose)? Doesn't seem like it, but 
I'm no expert in regulatory law.

Brian




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