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  • 1.  Biologic Investigative Drug Product Expiration Date

    Posted 21-May-2019 14:57
    Hi All,
    We have stability data  that indicates that our investigative tissue engineered product is stable out to 12 month. Previous data showed stability to 6 months. We want to change our expiraton date from 6 months to 12 months.
    Can I just report this as part of our IND annual report/DSUR?
    or should I send in an amendment to the IND specifically 3.2.P.8.1 where we state the expiration date, and 3.2.P.8.3 with stability data?

    Thanks,
    Gene

    ------------------------------
    Eugene Helsel
    Principal Consultant, Halloran Consulting Group
    ehelsel@hallorancg.com
    ------------------------------


  • 2.  RE: Biologic Investigative Drug Product Expiration Date

    Posted 23-May-2019 09:49
    Hi Gene:

    Jessica Kokosinski from G&L Scientific responding to your question. My Regulatory Affairs background is primarily in Biologics CMC (monoclonals, vaccines, blood products, and some cellular therapy products).

    Please note that my thoughts on your question are shrouded in assumptions and, since I don't have all of the relevant detail in hand, are based on the information shared. 

    Unless there is an outstanding prior commitment with the US FDA to submit new shelf-life data via the AR or DSUR, it may be better to amend the IND with the new shelf-life data. Keeping the IND updated via the amendment mechanism will help throughout development and eventually licensure of the product. 

    Thanks and all the best,




    ------------------------------
    Jessica Kokosinski
    VP Regulatory Affairs
    Warren NJ
    United States
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    Original Message


  • 3.  RE: Biologic Investigative Drug Product Expiration Date

    Posted 25-May-2019 17:43
    Dear Jessica and Gene,

    Usually in IND a sponsor will define the intended stability study duration and time points as part of a stability protocol. If a 12 month time point is already defined in your stability protocol submitted in IND, you don't need to submit the data in an amendment. Update it in AR or DSUR is sufficient. For US IND, there is no need to state expiration date for clinical materials. This expiration dating is only needed for EU IMPD.

    ------------------------------
    Gene Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
    ------------------------------

    Original Message


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