https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
This isn't probably the best link to FDA site, but was best I could quickly find.... read the very last paragraph.
One site has to be done on US. Other can be anywhere else (like EU as part of EMA approval).. only catch is both trial designs have to be acceptable to FDA
Ann: Invex Receives Written Response from FDA on Type C Meeting, page-14
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