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Hello @username Apologies for not seeing this sooner. Thanks for your question. To clarify, iterative submissions (i.e. different iterations within the same PAAB eFile) do not require light blue shading. Blue shading is requested for child files that are part of a series. The blue shading is used to identify the common copy between the child and the parent eFile. However, whether you’re renewing an iterative submission or a series parent or child submission, you would shade the copy yellow. Once the submission is a renewal, it is more helpful to reference the backfile to which the copy is 100% pickup rather than shading it in relation to a parent file where the copy may be as little as 60% common. When using the “express renewal” feature, we will not require that the shading be adjusted by virtue of the way in which the “express renewal” platform functions and the nature of the guarantee that nothing has changed.

Good morning @caitlinbyrne While “now available” as a stand-alone message is exempt, when it is paired with another marketing claim (route of administration), the piece is no longer exempt. This piece appears to require lowest level fair balance if restricted to the copy noted above.

Hello @tbalzarini Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.

Hey @cchristopoulos Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.

Good Morning @au3010 Please see Q&A 520

Good Morning @jennifer_cm The letter should be from the national body to support that it is widely used by Canadian health professionals. If you would like confirmation prior to building out a piece, the PAAB opinion service can be used to assess the guidelines.

Good morning @jdilly11 Apologies for missing this question earlier. It is possible. There are a number of things to consider, and the following should not be considered an exhaustive list. The mechanism of disease (MoD) must be supported by an authoritative source. There should be no inference that a particular part of the mechanism is a more impactful target than another. There should be no explicit or implicit outcomes of targeting the MoD. There should be complete separation from the drug MOA and nothing that is inconsistent with or contradicts the TMA would be considered. These are high-level guiding principles. All aspects of the Code should be considered when presenting MoD.

@jennifer-thomson Please see PAAB Code section 3.4, and 4.2.2 as well as PAAB resource PAAB Guidance Documents for Market Share Claims in Advertising and Retention and Market Share Claims. The reference to "data" within these resources is to the data itself. An attestation letter alone is insufficient. If a claim of #1 within a province can be supported by high quality data from a recognized source with acceptable methodological practices to reach such a conclusion, we can consider the claim. The piece would be required to have restricted distribution to the province mentioned.

Good Morning @alee What a great question. This one got us thinking. We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.

Hi @tk2022 Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.

Hi @alee A non-inferiority test that results in a "statistically non-significant difference" is a form of statistical analysis and would be required to support such a conclusion, and it is not appropriate to conclude non-inferiority (or similarity) based on nonsignificant test result in a study designed only for superiority as noted in the Guidance Document for Claims Based on Non-Inferiority Trials. The appropriate interpretation of this observation is that the test product failed to achieve statistical significance for superiority (i.e. it would not be considered a “positive clinical outcome”), which does not support a claim of “similarity”. Please also note that all clinical claims must be pre-defined, directionally consistent with the primary endpoint (confirmed through statistical evidence), and similar to the description in the domains section, overall scores require statistical significance as per sections 3.4, 3.5 and 3.6 of the Guidance document for the Use of Patient Reported Outcomes in Advertising, respectively .

Hey @maryssa There is currently no limit on number of “keywords”.

Hello @alee Provision 8 of the Guidance Document for Claims Based on Kaplan Meier Analysis does not apply to retrospective studies. The Guidance on Real-World Evidence/Data is intended for RWE/D and does not apply to (Kaplan-Meier analyses in) randomized, controlled trials. The use of multivariate analyses to identify prognostic factors associated with overall survival pertaining to a drug product may provide insights for future investigation but it also creates implications for subgroups with specific patient/disease characteristics that would not be acceptable in the absence of pre-planned evaluation of these subgroups (s. 1.4 of the Guidance on Real-World Evidence/Data for RWE/D and s. 3.1.1 of the PAAB Code for randomized, controlled trials).

Hello @jennifer_cm An attestation letter from Med/Reg confirming that only sites which have been approved will be listed is sufficient. When submitting, provide a standardized template of how the sites will be listed. This will allow sites to be added and removed without a need to re-review as this becomes an administrative feature.

Good Afternoon @mimi77 Please see PAAB Q&A 173, 467, 729.

Hey @laraholmes All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.

Hey @maryssa A search of the PAAB resources at paab.ca should turn up “What constitutes current medical opinion”. A search of “guidelines” on the forum should turn up 593, 743, 77, among other results. HTH.

@jennifer-carroll Thank you kindly for the clarification - this is helpful.