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  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. Demonstration Kit
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Demonstration Kit

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • K Offline
    K Offline
    KEOCA
    wrote on last edited by
    #1

    Demo syringes (with no active drug or placebo liquid) will be given to hcps who request to do their own injection training with patients rather than utilize the Patient Support Program to do so. The demo syringes will have a sticker that includes the brand name but identifies the syringe as a demo, for training purposes only. The syringe will come in a box with the brand name, which again will identify the syringe as a demo for training purposes only. The box will also include instructions of how to operate the demo syringe and these instructions were provided by the manufacturer of the demo syringe. This syringe is used by many other products so the instructions of how to operate the demo model (activation/ how to reset) will not be unique to the branded product. Does this box with its demo syringe and instructions require PAAB review? Our team is split on this and we would appreciate clarification. If this project does require PAAB review do we submit pdfs of the components as one file or as a series of related files? Thank you!

    Jennifer CarrollJ 1 Reply Last reply
    0
    • K KEOCA

      Demo syringes (with no active drug or placebo liquid) will be given to hcps who request to do their own injection training with patients rather than utilize the Patient Support Program to do so. The demo syringes will have a sticker that includes the brand name but identifies the syringe as a demo, for training purposes only. The syringe will come in a box with the brand name, which again will identify the syringe as a demo for training purposes only. The box will also include instructions of how to operate the demo syringe and these instructions were provided by the manufacturer of the demo syringe. This syringe is used by many other products so the instructions of how to operate the demo model (activation/ how to reset) will not be unique to the branded product. Does this box with its demo syringe and instructions require PAAB review? Our team is split on this and we would appreciate clarification. If this project does require PAAB review do we submit pdfs of the components as one file or as a series of related files? Thank you!

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      HI @keoca

      This would be considered a service-oriented vehicle and would be subject to review as it is part of the HCP-patient interaction in the context of the brand. It could likely be submitted as one file.

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      • D Offline
        D Offline
        dmauri
        wrote on last edited by
        #3

        @jennifer-carroll If the demo kit does not contain any instructions and consists only of a box and the demo device, is it still subject to review? Thanks in advance!

        Jennifer CarrollJ 1 Reply Last reply
        0
        • D dmauri

          @jennifer-carroll If the demo kit does not contain any instructions and consists only of a box and the demo device, is it still subject to review? Thanks in advance!

          Jennifer CarrollJ Offline
          Jennifer CarrollJ Offline
          Jennifer Carroll
          wrote on last edited by
          #4

          Hey @dmauri

          If the kit only contains a blank demo box and a demo device, it would not fall under PAAB’s scope. However, any information provided on the box (beyond product logo which has no promotional/therapeutic implications) would render the kit subject to PAAB review.

          D 1 Reply Last reply
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          • Jennifer CarrollJ Jennifer Carroll

            Hey @dmauri

            If the kit only contains a blank demo box and a demo device, it would not fall under PAAB’s scope. However, any information provided on the box (beyond product logo which has no promotional/therapeutic implications) would render the kit subject to PAAB review.

            D Offline
            D Offline
            dmauri
            wrote on last edited by
            #5

            @jennifer-carroll Thank you !!

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