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Questions mises à jour jusqu’au: 4 octobre 2021

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784

When constructing Fair Balance, under "Other relevant warnings & precautions," are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category.

When it comes to product specific questions, it is best to speak to the reviewer as they will be familiar with the brand and therapeutic area, and there may be other considerations within the TMA that determine if it is required. As a general rule of thumb, this type of statement from the warnings and precautions section would be required if implications/consequences are conveyed such as "not recommended" or "lower the dose".

783

Hello, I am the author of the Clinical Guide to Probiotic Products Available in Canada (and In the US). This is a resource independently reviewed by a group of experts in the field and published annually online and in print. Our project is supported by the unrestricted educational grant provided by the Alliance for Education in Probiotics, a group comprised of industry members. The Guide is designed as a practical tool to assist health care professionals when recommending evidence =based probiotics to their patients. My question is if this kind of product would be subject to PAAB review? I would appreciate any information you provide. Thank you!

Independent third party publications do not fall within the scope of PAAB. Content taken from the publication, or distribution activities by a manufacturer may render the activity advertising. This would not fall within the purview of the publications responsibilities. If the publication supports advertising content throughout, the advertising content may be subject to PAAB review. See PAAB resource: Guidance on which HCP materials require PAAB Review for additional information.

782

We have a product with a complex indication, requiring previous treatments, biomarkers, etc. We would like to create an algorithm that depicts the approved indication within a diagnostic/treatment framework. Can we utilize Guideline pathways (not recommendations) in order to put the indication in a larger clinical context? For example, we would depict the entire Guideline pathways for all possibilities, but only highlight/emphasize the approved indication portions leading to our product use.

Guideline recommendations and pathways, must be consistent with the TMA for the brands mentioned. When a treatment pathway or algorithm contains content which exceeds the TMA copy, it can be rendered unacceptable in advertising.

781

We have a product with an open indication (Product X for the treatment of Condition Y). Guidelines now suggest the use of Product X in combination with another product. Can we promote this combination in the context of Guideline recommendations (ie. not showing clinical data/claims)?

The presentation would be assessed to evaluate consistency with the TMA for both products.

780

If a third party group (e.g. patient advocacy) develops a DTC piece with mention of a brand- would it be subject to HC regulations? The message is by no means sponsored by the manufacturer, and no involvement from the manufacturer. Would this meet the definition of advertising?

Independently created and controlled content is not subject to advertising regulations. See the "Distinction Between Advertising and Other Activities" for additional clarification.

779

For how long can the word "new" or saying "now approved" can be used in promotion to announce a new prescription drug ?

Please see question 423.

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