We are trying to determine whether there is precedence in the industry for trials of a single compound and same indication to have more than 1 investigator brochure [IB], for example, a US IB and an ex-US IB. Often there are different versions of a protocol for different countries, but can this be done with IBs? And if regulatory agencies allow this, what are the complications related to a lack of a global single safety profile, DSUR complexities and challenges, and other scientific analyses challenges? Any experience and insights are appreciated.
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