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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!
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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!
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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@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!
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.
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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.
@jennifer-carroll Thank you !!
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