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  • 1.  IND for new indication needed if new sponsor

    This message was posted by a user wishing to remain anonymous
    Posted 25-Mar-2024 08:36
    This message was posted by a user wishing to remain anonymous

    If a sponsor purchased all rights to a compound from a prior sponsor and is now repurposing the same drug but for a subset of the original population that the IND was under, is a new IND needed or what is needed to proceed to Phase 3? 

    Thanks in advance



  • 2.  RE: IND for new indication needed if new sponsor

    This message was posted by a user wishing to remain anonymous
    Posted 25-Mar-2024 16:31
    This message was posted by a user wishing to remain anonymous

    Yes! You mentioned 'repurpose' would definitely require new IND!


    Original Message


  • 3.  RE: IND for new indication needed if new sponsor

    Posted 26-Mar-2024 11:03

    Since you are just narrowing the population to a subset of the current indication, I would suggest contacting the FDA Project Manager and asking if a new IND is required. 



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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


  • 4.  RE: IND for new indication needed if new sponsor

    Posted 26-Mar-2024 21:05

    Just changing sponsors does not require a new IND. If the new development program is for the same disease and just a subset population a new IND is not required. Although you could cross-reference to the old IND for much of the content, it will be so much easier just to continue with one IND.



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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    Original Message


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