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    • L

      NOCc and Guidance on Duration of Clinical Trials
      PAAB Code • • Lags

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      @jennifer-carroll Thank you.

    • A

      Advisory on Exclusivity Claims for Indications
      Guidance on Code Application • extneral advisory indication • • admin

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      Jennifer Carroll

      Hello @natbourre

      No, but the indication size should be proportional to the claim size Yes, it is acceptable to use the generic name.
    • Jennifer Carroll

      766 - Can you confirm if a CSR (Clinical Summary Report) is an acceptable document to support a data presentation from a published clinical trial. For example, the published clinical report presents pooled data results but the CSR captures this same endpoint by individual pivotal studies which garnered NOC for the drug. Additionally, can client share a portion of the document rather than the entire document given these reports are typically 2000+ pages. If it is possible to submit a partial version of the report, please confirm what parameters should be considered. thank you.
      Claims & Support/References for Claims • • Jennifer Carroll

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      Jennifer Carroll

      Hey @constance

      Due to their size, we often receive a portion of the report. The advertiser must include any content that is relevant to the APS presentation in question.

    • G

      Regarding the use of PROs in promotional materials:
      Claims & Support/References for Claims • • GeoffLS20

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      Jennifer Carroll

      Hello @geoffls20

      The document Guidance on Patient Reported Outcomes provides the limitations for use of PROs. It is not required that the study identifies it as a “key” secondary endpoint. Note that it must be identified as a “secondary endpoint” and this must be disclosed in the APS per code section 3.1.10.

      The discloser of failed secondary endpoints is required when they are closely related to the other endpoints so as not to be selective. (s.5.12)

    • palanski

      Disclosure requirements of competitor names/schedules
      PAAB Code • • palanski

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      Jennifer Carroll

      Hello @palanski

      PAAB Code s2.2 pertains only to the promoted product(s). There are separate code sections that relate to other products (e.g., acknowledgement of trademarks where relevant). The sponsor’s legal department can help you ensure that you are meeting legal disclosure requirements for those other products.

    • M

      Use of guideline criteria in a promotional branded piece
      Claims & Support/References for Claims • • mhe

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      Jennifer Carroll

      Hello @mhe

      Good question. Basically, all copy in a branded piece has implications for the brand. When you present the definition/criteria for “optimal benefit” you are suggesting that the product gets patients to “optimal benefit”. This is likely not substantiated as the clinical endpoint in the study was probably not “optimal benefit”. Claims, both direct and implied, must be supported by statistically significant findings from a well designed, published study.

      With respect to adding a disclaimer, it is not sufficient to state or imply claims and then use a disclaimer to off-set them. That which cannot be supported should not be stated or implied.

      Happy Holidays!

    • M

      Consumer-facing Institutional Messages
      DTCA/I, consumer secondary audience • • matt.s17

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      Jennifer Carroll

      Hello @matt-s17

      The Distinction Between Advertising and Other Activities states:

      An institutional message is defined as a communication (e.g., brochure, published article, prospectus, annual report, etc.), which provides information about a pharmaceutical manufacturer, or other institution, concerning its philosophy, activities, product range (by name), financial details, area of future development or research, etc. Such a message may be a nonpromotional activity in the following circumstances:

      the purpose of the communication is clearly to provide information about the institution rather than about the drugs being marketed, developed or researched, information about the drugs being marketed, developed or researched is limited to the name and therapeutic use of the drug, and no emphasis is given to any one or more products, or their benefits

      The activity described above seems to place emphasis on a particular therapeutic area and class of products which the sponsor has a vested interest and therefore would fall in the scope of advertising. If the intent is for the messages mentioned above to exist in the consumer space and be targeted at consumers only, it would be subject to consumer advertising regulations and an advisory opinion may be provided by PAAB, AdStandards or sent directly to Health Canada. If there is a possibility that the message/campaign will be targeted at HCPs in any way, it would be subject to the PAAB Code and should be reviewed by PAAB.

    • Jennifer Carroll

      Tips and clarifications for file submissions
      Newsletters/Blogs • newsletter tips & best practices for efiles • • Jennifer Carroll

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    • N

      Inquiry on observational study material
      PAAB Q&A • • Nimisha

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      Jennifer Carroll

      Hey @nimisha

      Unfortunately, we cannot provide this confirmation as it does not appear that the project will meet the criteria outlined in the Distinction Document (it will inherently be branded). We suggest submitting for an opinion to receive more specific feedback in this specific case.

    • T

      Video-in-print and ISI req'ments
      Miscellaneous • • TNT

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      @jennifer-carroll Thank you for the clarification.

    • M

      Converting a full colour layout to B&W - does PAAB need to see this?
      PAAB Q&A • • Maryssa

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      Jennifer Carroll

      Hello @maryssa

      If there are no other changes, the files should be submitted as an FYI. If the review of the FYI prompts comments, it would be required to be submitted as a new file. If no changes are required, it can be considered solely as an FYI. When preparing the black and white version, consider things like legibility of all copy (e.g., no reduced contrast).

    • Jennifer Carroll

      PAAB eFiles Tag Report 2022
      Newsletters/Blogs • tags & tickets • • Jennifer Carroll

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    • M

      Clinical vs. Non-clinical claims
      Guidance on Code Application • • mhe

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      Jennifer Carroll

      Hey @mhe

      The answer is nuanced and context driven. While dosing has clinical relevance for appropriate use of the product, the convenience of once daily dosing does not necessarily translate into a clinical outcome such as adherence, safety, and/or efficacy. As such, a claim of “convenient once-daily dosing” would not require a disclaimer of “Clinical significance unknown” but it would not be permissible to present it in a context that suggests unsubstantiated significance.

    • A

      Guidance on Risk Management Tools (September 2016)
      Guidance on Code Application • • admin

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      @admin We note that modifications to RMTs require PAAB resubmission. Would this still be the case for a product logo or legalese update that does not alter any of the other content in the RMT? If PAAB resubmission is required, is there a way for a reduced fee to be applied (we note that updated legalese or logos are not part of the criteria for "Minor Update" reviews).

    • Jennifer Carroll

      Feedback request regarding the PAAB's ARO service offering
      Announcements • external aro • • Jennifer Carroll

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    • D

      ARO Q&A #8: Time-sensitive Announcements
      Accelerated Review Options (AROs) • • danthony

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      @danthony Thank you for the clarification!

    • palanski

      Consumer landing page disclaimer on HCP-facing materials
      Claims & Support/References for Claims • • palanski

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      Jennifer Carroll

      Good morning @palanski

      Great question. There has been an increase in HCP assets that direct HCPs to pre-gate spaces containing consumer content. For transparency, when you are directing this audience to a message not intended for them, they should be made clear of this fact.

      URLs that direct HCPs to landing pages that contain only administrative messages such as “log in here” would not require this disclaimer.

    • D

      Level of fair balance required for guidelines claims
      Claims & Support/References for Claims • • dmauri

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      @jennifer-carroll Thank you for your helpful response!

    • L

      Unbranded ad link to guidelines
      Linkage Issues • • llmktg

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      Jennifer Carroll

      Hello @llmktg

      Acceptability would be assessed during the review process. Linking to the homepage/cover page of the complete guidelines, is likely permissible with the understanding that they are recognized Canadian consensus guidelines. For unbranded ads, the linkage should not contravene the principles outlined in Code section 7.5. There are some scenarios where it could be challenged. As an example, if the unbranded piece speaks to a drug class for which the use is off-label in the guidelines.

    • J

      Abstracts and HCP websites
      PAAB Q&A • • joao.borges

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      Jennifer Carroll

      Hello @joao-borges

      When you link advertising and non-advertising, everything becomes advertising. Even though the abstracts are on a third-party site, you would be leading them there from an advertising space and in the context of promotional material; the abstract would become advertising. The abstracts would have to be reviewed to ensure that they meet advertising requirements. For example, you could not link to an abstract about off-label use of the product as this would be off-label promotions. Furthermore, the abstract content would be reviewed as if it were APS copy. A quick review of the Health Canada document “The distinction between advertising and other activities” may help provide additional information about questions to ask when assessing if an activity would be considered advertising.