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  • 1.  IND Transfer of sponsorship

    Posted 22-May-2018 15:25
    Can somebody please explain what is it IND Transfer of sponsorship, and when is it supposed to be submit?

    Thanks

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    Masa Razic
    Regulatory Affairs Specialist
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  • 2.  RE: IND Transfer of sponsorship

    Posted 23-May-2018 08:52
    The applicant submitting an original IND and responsible for the clinical trials conducted under the IND is considered the Sponsor, whether commercial or research.  If the Sponsor wants to transfer the ownership of the IND to some other entity, it is considered a Transfer of Ownership or Sponsorship.  This is done through a process of the original Sponsor and the new Sponsor submitting letters to the IND assigning and receiving ownership of the IND.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: IND Transfer of sponsorship

    Posted 23-May-2018 10:17
    Does that mean that transferring the BLA, means automatically that you need to transfer your IND as well?
    I am brand new in the area, so I am trying to learn


    Thanks a lot,

    Maša

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    Masa Razic
    Regulatory Affairs Specialist
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    Original Message


  • 4.  RE: IND Transfer of sponsorship

    Posted 23-May-2018 21:03
    ​Transferring the BLA to a new owner does not mean that you need to transfer the IND containing the same biologic entity. Are you the owner of the biologic? If so, you can keep your IND active. Your agreement should reflect this should you want to keep your IND for conducting your own studies with your own biologic entity.  Review your agreement and consult with your legal.

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    GRSAOnline
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    Original Message


  • 5.  RE: IND Transfer of sponsorship

    Posted 24-May-2018 10:59

    The process for transferring ownership of a BLA is a little more involved than the transfer of an NDA or IND as described in 314.72. Biologics also involves the need to have a US License number.  I would suggest you contact your FDA Project Manager for guidance.  Unlike the process for IND/NDAs, I believe FDA will have to approve the transfer for a biologic. We transferred ownership of two biologics (one in CBER and one in CDER) at a previous company I was at and it took about 6-8 months for FDA to approve, but I think that was due to both CBER and CDER being involved and having to coordinate the approval across divisions. Hopefully the sponsor you are transferring to already has a biologic and therefore already has a US License – otherwise FDA will need to assign/create a new US License # for them. The US License # appears on the label. Typically when you transfer ownership of an NDA or BLA, the IND is also transferred but it's not required – it depends on the nature of the agreement between the two companies.

     

    Tom

    Chicago




    Original Message


  • 6.  RE: IND Transfer of sponsorship

    Posted 24-May-2018 11:13
    GRASAOnline provided good advice...that you should consult with legal, as it depends on the arrangement between the companies.  Typically, the associated IND would be transferred with the BLA.  This would require you to submit transfer of sponsorship for each the BLA and IND.  If the new sponsor needs to fulfill any postmarking commitments or plans to conduct any additional studies, they would be conducted under the associated IND.

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    Bridgette Kunst MA, RAC
    Managing Director
    Bridge Regulatory Affairs, LLC
    bkunst@bridgereg.com
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    Original Message


  • 7.  RE: IND Transfer of sponsorship

    Posted 23-May-2018 11:03
    Review 21 CFR 314.72.  

    "21 CFR 3 14.72 covers the transfer of ownership of an approved application. The application holder must submit
    a letter or other documentation to FDA indicating all rights to the application have been transferred to the new owner
    as of the transfer date.  When ownership of an approved application is transferred, the new owner assumes all of the former owner's commitments to application agreements, promises and conditions. The new owner must submit a signed application and a letter stating acceptance of such commitments. The new application holder also must provide FDA with the effective date for the change in ownership and a statement that either the new owner has a complete copy of the
    approved application, including supplements and records, or has requested a copy of the application from FDA's files.
    Once transferred , the new application holder assumes regulatory responsibility for the application. As such, the
    new application holder must inform FDA of any change to the approved application under 21 CFR 314.70. Changes to
    the drug product's label, or labeling to change the product's brand or the name of its manufacturer, packer or distributor
    can be submitted in the next annual report."  (direct from Fundamentals book)

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    KATHERIN HARRIS
    San Antonio TX
    United States
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    Original Message


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