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  • 1.  Timing for IND review

    This message was posted by a user wishing to remain anonymous
    Posted 24-May-2022 09:18
    This message was posted by a user wishing to remain anonymous

    Hello,

    What are the expectations for review of IND amendments by FDA? FDA is required to review a new IND within 30 days before a sponsor begins clinical investigation.  21 CFR 312.31 (c) indicates that amendments are to be submitted 30 days apart but doesn't address the review of amendments by FDA.  Is there guidance or legal language addressing the review time for amendments?  

    Thanks


  • 2.  RE: Timing for IND review

    This message was posted by a user wishing to remain anonymous
    Posted 24-May-2022 15:55
    This message was posted by a user wishing to remain anonymous

    IND amendments are reviewed and the FDA only gets back if there is an issue else no response and you just continue your study!
    These are very simple questions and I'd suggest you hire a RA professional!