Regulatory Open Forum

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  • 1.  IB Update

    Posted 22-Dec-2020 10:45

    Dear community,

    My company submits an IND for a Phase 1. And FDA provides some non-hold comments.
    Some of these comments require us to correct and add/update certain information in the previously submitted IB.

    My question is:
    Do we need to provide an IB amendment ? Or to prepare a new version of the IB ?

    Thank you for your help.

    New regulatory associate


  • 2.  RE: IB Update

    Posted 22-Dec-2020 13:46
    Edited by Scott Bishop 22-Dec-2020 13:46

    Hello Nathalie,

    In my experience, if the feedback was provided in a formal written format (letter, response, etc.) they typically provide direction for providing that information.  Is your IND still under review or have they issued a decision?  If you are still in the interactive review period an email with the revised document might suffice.  Ultimately, I would recommend an informal (email or call) contact with your lead reviewer to confirm.  If your team agrees to make the changes, I would process it through your QMS to track changes - whether you provide it for review to FDA.

    Scott Bishop
    Houston TX
    United States

  • 3.  RE: IB Update

    This message was posted by a user wishing to remain anonymous
    Posted 22-Dec-2020 15:17
    This message was posted by a user wishing to remain anonymous

    Yes, IB amendment for current distribution to the IRB/FDA, Investigators but at the annual update version 1.1.