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Rimsys 2024 RegEx AMA
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Notification of foreign regulatory status update in other Regions/Countries

  • 1.  Notification of foreign regulatory status update in other Regions/Countries

    This message was posted by a user wishing to remain anonymous
    Posted 01-Feb-2023 08:41
    This message was posted by a user wishing to remain anonymous

    Hi all,

    For a global Phase 1/2 study, if FDA is placing the initial IND on Clinical Hold, would you notify EU countries where the CTA is already approved but where the study has not been initiated yet? Is there a specific guidance in Europe asking to declare it? 

    Thank you very much,

    Kind Regards


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