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Re: Hike post# 203228

Monday, 06/06/2016 6:01:18 PM

Monday, June 06, 2016 6:01:18 PM

Post# of 409055
After reviewing the FDA's Industry Guidance document

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf

Category I includes the product having been manipulated. Therefore, I chose to read the slide as having been worded too succinctly in not making that clear.
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