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Tuesday, May 04, 2021 2:55:46 PM
The part the you bolded is if the study is NOT conduct under IND.
If it is conducted under IND then the study still must comport with all relevant FDA regulations as if it were being conducted within the United States.
So that being said the FDA would not have had any reason to inspect or validate any of the Nutra data if it was conducted under IND.
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