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Comparator drug with Japanese label use in Clinical trials?

#1
Hello all,

We have a sponsor who currently uses a drug(Mfg in US) as a prophylactic in Clinical trial however it is very expensive and the trial is nowhere close to finish so the sponsors want to send the same bio-equivalent drug to the US from Japan however the drug label is in the Japanese language. Does anyone have any input on this scenario?
 
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