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  • 1.  Shelf-life extension post approval CBE-0 or CBE-30

    Posted 18-Apr-2023 15:53

    Hi,

    I would like to know what is the process for submitting the request for shelf life extension with new data after NDA approval. We have submitted the product with 12 M data for 1 lot and got 18M shelf-life approval. Our product was approved and now we want to submit 18M data for 1 lot and request 24M shelf life. 
    Will this amendment be considered CBE-0 or CBE-30? Would we need to wait for FDA approval? 

    Thank you,



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    Valeria Shkuratova
    Canada
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  • 2.  RE: Shelf-life extension post approval CBE-0 or CBE-30

    This message was posted by a user wishing to remain anonymous
    Posted 19-Apr-2023 08:10
    This message was posted by a user wishing to remain anonymous

    This will not be considered an amendment rather supplement! Did your approved NDA contain post approval stability protocol? If so, check the maximum number of months that you committed to follow for the stability, and how many lots (usually 3 lots)! If the max is 24 months then it can be an annual report rather than CBE-0. If you wish to be conservative one can submit CBE-0


    Original Message


  • 3.  RE: Shelf-life extension post approval CBE-0 or CBE-30

    Posted 19-Apr-2023 09:10

    Hi 

    We committed to 24M as that what we want, but currently we only have 18M data. If we do  not have real time data yet and want to extend shelf-life to 24M right now based on 18M, I thought there has to be some FDA approval. 
    So what you are saying we do not have to notify FDA in  advance at all and just change stability from approved 18M to 24M and let know FDA of this change only in annual report?



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    Valeria Shkuratova
    Canada
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    Original Message


  • 4.  RE: Shelf-life extension post approval CBE-0 or CBE-30

    Posted 19-Apr-2023 13:37

    I could not find your exact scenario addressed in any guidance. You could submit as a CBE-30 and if FDA determines it requires prior approval they will notify you and reclassify as a PAS. I assume in your original NDA that you committed to placing batches 2 and 3 on long term (through shelf-life) and accelerated (6M) stability in accordance with ICH Q1A, if not I would include this commitment in your supplement.  I would also suggest you include a protocol specifically for extension of shelf-life. This will allow you to extend shelf-life as long term data is obtained and only have to report via an annual report as described in FDA Guidance: Changes to an Approved NDA or ANDA Section XI. MISECLLANEOUS CHANGES.



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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


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