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  • 1.  Human Factors data for mAbs administered via pre-filled syringes or autoinjectors

    Posted 10-Oct-2020 21:03
    Dear RA professionals,

    Do we need to submit human factors data to the IND before introducing PFS or autoinjectors into registration trials? My current assumption is to submit the human factors data only in the BLA. Please advise.

    Many thanks for your time! 

    Best,
    Deep

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    Deep Shah, MS
    Global Regulatory CMC Lead
    Seattle, WA
    ------------------------------


  • 2.  RE: Human Factors data for mAbs administered via pre-filled syringes or autoinjectors

    Posted 11-Oct-2020 08:01

    Dear Deep,

     

    You should certainly "address" HF in your IND.  However, there are several factors that influence the information necessary to submit regarding your studies that are not clear from your question.

    • Are these products are to be used by HCP or self-administered at home by patients and caregivers
    • If at home, are there distinctive or unique disabilities or characteristics of your users that would impact the usability in a way not that would make them different than other user groups who use these devices (for this or other drugs)
    • Are your delivery systems, including your Instruction for use or labeling, relatively standard or in any way novel.

     

    These factors would influence what, if any data needed to be submitted in the IND before starting the study.

     

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     

     

     

     




    Original Message


  • 3.  RE: Human Factors data for mAbs administered via pre-filled syringes or autoinjectors

    Posted 11-Oct-2020 15:57
    Dear Deep,

    No. You don't need it in IND for your registration trial however, it is your own risk whether you are willing to take if your registration trial without any human factor study (e.g., pilot) done. I have seen some decided to take the risk and only submitted the study results in BLA and got the BLA approved. You need to do your own risk assessment before you decide to take the risk.

    ------------------------------
    Jingdong Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
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    Original Message


  • 4.  RE: Human Factors data for mAbs administered via pre-filled syringes or autoinjectors

    Posted 12-Oct-2020 17:15
    Hi Deep,

    There is no requirement to do so, even though the FDA would like all HFE work to be completed prior to registration trials (in reality, this is rarely the case).  It is always a good idea to discuss your HFE program with the FDA at your formal meetings (e.g. EOP2) as there may be issues to discuss such as bridging studies (e.g. PK studies to support bridging exercise).

    It really comes down to what risk your organization is willing to accept.

    Hope this helps!
    Bobbi

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    Bobbi Drais, MS RAC
    President
    Drais Regulatory Consulting, LLC
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    Original Message


  • 5.  RE: Human Factors data for mAbs administered via pre-filled syringes or autoinjectors

    Posted 13-Oct-2020 02:40
    It's all about "risk". I believe this is the golden word of this century.
    Even if most of the risk assessments performed by the manufacturers are vague and meaningless. Just another obligation...

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


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