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FDA responsiveness to Single Patient and Emergency IND requests?

  • 1.  FDA responsiveness to Single Patient and Emergency IND requests?

    This message was posted by a user wishing to remain anonymous
    Posted 24-Mar-2020 10:46
    This message was posted by a user wishing to remain anonymous

    HI All and hope everyone in this community is doing okay and/or has the resources they need.  On to my work question:  Has anyone had experience since the Covid-19 situation emerged with submitting non emergency and/or emergency research INDs to FDA? If so can you share any differences you have noted? (timing to process, additional justification needed to get processed, etc).  I appreciate hearing about your experience either as the cross referencing commercial sponsor or as the IND holder planning to administer the investigational product.