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Placebo deviations and recall

  • 1.  Placebo deviations and recall

    This message was posted by a user wishing to remain anonymous
    Posted 25-Feb-2021 17:13
    This message was posted by a user wishing to remain anonymous

    Hello - does anyone have tips on how to manage deviations involving placebo drug product and  the analysis on need for potential recall - in clinical not commercial context? I have not found any guidance that talks about it specifically but may not be looking in right place