Regulatory Open Forum

 View Only

  • 1.  Terminating an IND

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2022 10:43
    This message was posted by a user wishing to remain anonymous

    Can an IND be closed with the FDA after all participants are off study but the study will remain open for data analysis with the IRB?


  • 2.  RE: Terminating an IND

    Posted 24-Feb-2022 07:50
    Yes, with one caveat. I would make certain that there was little or no potential for safety findings as you continue to follow the participants.

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

    Original Message


  • 3.  RE: Terminating an IND

    Posted 24-Feb-2022 08:47
    Anon,

    Yes. I routinely withdraw the IND (312.38) after all subject interaction is complete, site PIs have signed-off on the eCRFs and the database is locked, all study drug is destroyed/accounted for, and the sites have closed-out with their reviewing IRB (all research activities are finished at the site).

    Our "main" IRB stays open while we analyze data and write publications (this may be an academia thing).

    David

    ------------------------------
    David Jensen PhD, RAC
    Regulatory Affairs Scientist
    Durham NC
    United States
    ------------------------------

    Original Message


  • 4.  RE: Terminating an IND

    This message was posted by a user wishing to remain anonymous
    Posted 24-Feb-2022 09:52
    This message was posted by a user wishing to remain anonymous

    What about submitting data to the IND if you close the IND?
    Original Message


  • 5.  RE: Terminating an IND

    Posted 24-Feb-2022 10:23

    If the IND is withdrawn/closed, you are done with it, so you lose the ability to submit further info/data. If you need to continue to submit things to the IND, then it needs to remain open/active.

     

    David

     

     

     

    David Jensen, Ph.D., RAC

    Regulatory Affairs Scientist

     

     

    RAC_badge_small

     

     

     

     




    Original Message


  • 6.  RE: Terminating an IND

    Posted 24-Feb-2022 10:35
    I had the same question as the Anon, so then you don't have the intention of submitting the CSR for the phase 1 study to the IND? or you meant after submitting the CSR it would be prudent to close the IND?

    ------------------------------
    GRSAOnline
    ------------------------------

    Original Message


Related Content