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Friday, January 08, 2010 12:44:05 PM
i have seen the post from the FDA website about the relationship with labeling of course, but some have ran with it that this is the only use for intended use.
It is used for the application, the determination of equivalence, and then labeling if it moves through that process.
I poat a FDA flow chart earlier this week that clearly shows they use intended use for determination. Also the new FDA document as shows it in section A pg 10.
So it may be wishful thing, or he didn't want to say something that would harm the company. Which is an appeal to your idea that Dean wouldn't do that with drugs, so i think that should apply here also.
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