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Rimsys 2024 RegEx AMA
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SDV requirement considering filing and label for negative study

  • 1.  SDV requirement considering filing and label for negative study

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jan-2021 17:08
    This message was posted by a user wishing to remain anonymous

    Hello All,

    Do you need 100% SDV for label update/filing based on results from a negative study in US/EU?

    Thanks in advance!


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