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  • 1.  submitting one IND with two protocols

    This message was posted by a user wishing to remain anonymous
    Posted 22-Sep-2020 13:20
    This message was posted by a user wishing to remain anonymous

    Hello,
    is it possible to submit a full original IND with two protocols covering two slightly different studies? The rationale is to get feedback on both protocols. Should FDA demand data that is not available yet, is it further possible to withdraw one of those protocols and still get the IND cleared with the other one?

    many thanks for your input!


  • 2.  RE: submitting one IND with two protocols

    This message was posted by a user wishing to remain anonymous
    Posted 22-Sep-2020 16:54
    This message was posted by a user wishing to remain anonymous

    I have submitted multiple protocols in an IND many times.

    But if you want FEEDBACK from FDA, you may be better off with a pre-IND meeting.

    If FDA puts a hold on your IND due to a safety concern about one but not both of your protocols, yes, you can withdraw your protocol to still get authorization to proceed.