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  • 1.  IND annual report question

    This message was posted by a user wishing to remain anonymous
    Posted 03-Dec-2021 14:39
    This message was posted by a user wishing to remain anonymous

    Hi,

    I have a question about US IND annual report. Our company recently completed a phase I clinical trial, and the CSR will be finalized soon. 

    Do we still need to submit an annual report to the FDA next year? and when can we stop submitting the annual report? 

    Thanks a lot!


  • 2.  RE: IND annual report question

    Posted 04-Dec-2021 08:09
    Yes. You have to submit an IND annual report every year until the IND is not longer active.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: IND annual report question

    Posted 05-Dec-2021 15:00
    I agree with Glen, you do need to submit an annual report. You can withdraw the IND when it is no longer needed if you meet the conditions in 21 CFR 312.38(b).

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    Ruth Collins RAC
    Manager Regulatory Affairs
    Fort Worth TX
    United States
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    Original Message


  • 4.  RE: IND annual report question

    Posted 06-Dec-2021 10:43
    I agree with the previous suggestions. This being Phase I study, you must include a summary of adverse events (grades 3, 4, and 5). I generally include relevant "new clinical and nonclinical studies" from the literature so the reviewers know what we are doing. List any deviation from the protocol during the study or any foreseeable future plans. I am sure you must be familiar with it, but just in case, the submission date is due within 60 days of the anniversary date that the application went into effect. I hope this helps.
    Israr

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    Israr Ansari PhD, MS, RAC
    Sr. Scientist - Clinical Trials
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    Original Message


  • 5.  RE: IND annual report question

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2021 10:49
    This message was posted by a user wishing to remain anonymous

    Refer to your IND acknowledgment letter for specific instruction on annual reports.  Annual reports typically need to be submitted as long as the IND is active.
    Original Message


  • 6.  RE: IND annual report question

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2021 10:50
    This message was posted by a user wishing to remain anonymous

    So in your opinion annual report is only related to clinical trial? and then you are expecting an Annual reporting would stop??? Please, I strongly recommend that you hire an experienced RA professional.
    Original Message


  • 7.  RE: IND annual report question

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2021 10:50
    This message was posted by a user wishing to remain anonymous

    The IND annual report has to be filed as long as the IND is active.  This is irrespective of completing the Phase 1 study and submitting the CSR to the IND.
    Original Message


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