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Thursday, 07/28/2016 12:53:22 AM

Thursday, July 28, 2016 12:53:22 AM

Post# of 399479
by the way it is incorrect that the panelist asked what an empty stomach is, the question was regarding guidance about the FDA recommendation re timing of intake around meal time. From the transcript:

So just as we talked about a standard meal
5 and what that would mean, what exactly does it mean
6 to take on an empty stomach? What's the
7 definition?
8 DR. HERTZ: This is Sharon Hertz. I'm not
9 sure that I can claim this to be a standard
10 definition. But for labeling, it generally means 1
11 hour before or 2 hours after a meal. There may be
12 circumstances, based on the product and the
13 clinical setting, where that is modified based on
14 specific data.
15


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