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  • 1.  Promotional Regulations

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2018 11:13
    This message was posted by a user wishing to remain anonymous

    Dear Experts-

    Prior to marketing, are sponsors allowed to perform any promotional activities?

    Thanks you so much!


  • 2.  RE: Promotional Regulations

    Posted 11-Sep-2018 08:54

    You cannot make any claims about efficacy or safety prior to approval.  However, there are ways to get the name of the product out as a premarket activity without making claims, such as at meetings.  Note that FDA recently issued guidance on talking to payors to negotiate reimbursement prior to approval, which would necessitate discussing efficacy and safety, but there are all kinds of caveats around that activity.



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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Promotional Regulations

    Posted 11-Sep-2018 10:00
    As usual, the answer is "that depends" - first of all, we'd need to know what kind of product - the regulations are different for drugs, devices etc.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: Promotional Regulations

    Posted 11-Sep-2018 10:29

    Agree with Glen. Unapproved/uncleared devices if used in conferences should be marked "not for clinical use" or "approval pending/ IDE device". its a tight rope to walk because any 'promotional material' you use in this time cannot make any claims. A little counterproductive.



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    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
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    Original Message


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