Regulatory Open Forum

 View Only

  • 1.  Shelf life extension of DES during clinical trials

    Posted 22-Apr-2014 07:58
    All,

    We are at the begining of clinical trails for drug eluting stent systems (DES). The preliminary shelf life was set at 6 months after discussion with the FDA. We manufactured additional systems from each lot in order to perform mechnical and analytical test and extend the shelf life. How can we determain the new shelf life, assuming the tests pass their accepatnce criteria?

    Thank you,

    Hani 

    -------------------------------------------
    Hani Rauch
    Medinol
    Tel Aviv
    Israel
    -------------------------------------------


  • 2.  RE:Shelf life extension of DES during clinical trials

    Posted 23-Apr-2014 12:49
    Hani,

    Are you asking what mechanism (notification) to FDA is needed or are you asking a different question? Did you agree on a stability protocol with FDA that goes beyond 6 months?

    Dar

    -------------------------------------------
    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:Shelf life extension of DES during clinical trials

    Posted 23-Apr-2014 13:57


    -------------------------------------------
    John O'Neill
    John ONeill Enterprises LLC
    San Mateo CA 94404
    United States
    -------------------------------------------
    Hani,

    If you have the original stability studies used to justify the 6 month shelf life still in the chambers with sufficient samples remaining, I would continue those (for the duration of the trials if possible).  You will want to identify an appropriate model for calculation of shelf life (some have applied Arrhenius to DES) using stability-indicating data from an accelerated condition and launch new studies utilizing lots representative of those in the Clinic with samples placed at both the long term storage condition and the accelerated condition. There is an FDA Guidance that includes stability of combination products such as DES.  Continued dialogue with the FDA concerning your plans is always a priority.

    Regards,

    John O'Neill



    Original Message