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  • 1.  CMC Filing Requirements for Professional Sampl

    Posted 21-Feb-2024 11:43

    Hi everyone, 

    Please advise if there are specific FDA guidances that outline CMC filing requirements for professional samples or share your industry experience. I have seen a few different approaches adopted, from filing as a NDA supplement and in an annual report, to some peers suggesting they don't need to be filed at all. Similarly, is there a requirement to drug list professional samples?

    Regards,

    Laura. 



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    Laura Morley
    Senior Regulatory Affairs Associate CMC
    Gilead Sciences Inc. - ENTERPRISE
    Foster City CA
    United States
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  • 2.  RE: CMC Filing Requirements for Professional Sampl

    Posted 22-Feb-2024 09:12

    Laura,

    This is a broad question, a lot of what needs to be done depends on the nature of the professional samples. At a minimum, you would need to submit the labeling for the samples which need to contain language specific to samples e. g.. not for sale, professional samples only, etc. Obviously, if different bottle size  or tablet count would need appropriate stability.

    Regards



    ------------------------------
    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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    Original Message


  • 3.  RE: CMC Filing Requirements for Professional Sampl

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2024 09:13
    This message was posted by a user wishing to remain anonymous

    Yes, drug samples are considered commercially distributed product and must be listed.

    We do not include drug samples in the How Supplied section of the USPI and do not include the labeling (carton) in Module 1.14.2.1 as approved FDA labeling. We submit sample labeling (carton) as promotional material under Form 2253.


    Original Message


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