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Reply To: Labeling marketed productsJune 27, 2020 at 3:21 am
I would be more concerned about using non-FDA approve material in a clinical study from Regulatory & Legal perspectives. I have come across strong push back when I imported (was planning to import) unapproved medications as both departments felt that there was high risk. Is the product a prescription product in the ex-US country(-ies)? If yes, how are you “dispensing” it without a prescription?