Hi @dmauri This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.

Hey @mimi77 This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.

Hi @hollymed Please see this PAAB Forum Q&A

Hi @chagali-toney-0 Per the Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc “3. For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted.” Please note that this does not state “verbatim”. However, it should be interpreted to mean that no data from outside of the PM can be presented.

Hello @gmc Hard to say whether this is even acceptable without looking at the study, but as a general question, we can state that this would require highest level fair balance. It is an implied claim of efficacy which would likely require quantification from the study (i.e., presentation of data). If it was stopped due to safety concerns, that would also prompt inclusion of that information and render it subject to highest level fair balance. With respect to “what other data is required for it’s inclusion?”, this is a review specific question. Please submit for an opinion as there are a number of factors that would need to be considered.

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.

Hello @jdilly11 Yes. The internet (web banner to website) would be considered the same tool/directly linked to the web based banner ad. Note that they should be taken directly to the highest level (i.e. not a landing page with a link to the highest) and there should be no additional effort (e.g. they are not required to pass a gate. They should have already been validated as an HCP to see the banner ad.).

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).

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

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.

Hey @tk2022 It sounds like this might be a specific question about a specific case. We’d suggest submitting for review as the forum is guiding principles. Each case is assessed based on it’s merits in the context of all relevant documents. The answer provided below is with the caveat that it is a general response. In general, an RWE study is not excluded from advertising based on a pre-planned evaluation of a subgroup which would be within the limitations of the indication. “Consistent with the TMA” with respect to patient population states “1.1.2 Patient population: The APS presentation must be derived from analysis of patients that fall within the indicated population and are aligned with any relevant contraindications from the TMA. In instances where an overall study population exceeds the product’s indication, it may be possible to present data from a pre-planned patient subset that reflects the indicated patient population or relevant subset thereof.”

Hello @tk2022 The feature of being phase 3b/4 does not in and of itself disqualify a study from either RWE or study duration.

@jennifer-carroll thank you so much!

Hello @jdilly11 PAAB code section 3.1.1 requires that clinical claims are based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. Unpublished data would not be considered sufficient. If a study has been accepted for publication and completed the peer-review process (i.e. final manuscript is approved and awaiting official publication), PAAB can accept a letter from the editor confirming the future publication of the manuscript as presented in the submission.

Hi @rlevit1 The PAAB does not have a single guidance document dedicated specifically to defining “consistent with the TMA”. While many of the principles of the CFL guidance can be considered analogous to PAAB requirements, we suggest referring to and applying only Canada-specific guidance, as ultimately this is the only guidance describing compliant advertising in Canada. Familiar principles such as scientific accuracy (Code Section 2.1), restriction to the approved use and population (s3.1), and appropriate communication of risk-benefit profile (s2.4) are all required by the PAAB code, among others; however, consistency with the TMA as a whole depends on the type of claim and/or evidence posited. Some resources describing consistency with the TMA relevant to certain contexts include: Guidance on Subgroup Analysis (https://www.paab.ca/resources/guidance-on-subgroup-analysis/) , Noninferiority Trials (https://www.paab.ca/resources/guidance-on-noninferiority-trials/), and Secondary Endpoints (https://www.paab.ca/resources/guidance-on-secondary-endpoints/) all describe consistency with the TMA specific to these analyses. Guidance on Real-World Evidence/Data (https://www.paab.ca/resources/guidance-on-real-world-evidencedata/). Section 1.1 describes consistency with the TMA with respect to Real-World Evidence/Data; points 1.1.1-1.1.4 can generally be applied to any randomized controlled trial. Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising (https://www.paab.ca/resources/guidance-regarding-duration-of-clinical-trials-used-as-reference-support-in-advertising/). Some principles in this guidance originate from the CFL guidance. Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc (https://www.paab.ca/resources/guidance_on_advertising_for_drugs_with_notice_of_compliance_with_conditions_nocc_feb_2018_typofix_docxpdf/), which precludes inclusion of any studies or data not found in the TMA.

Hi @gmc This would be considered a review question. Please submit for opinion or full review. Note that other copy and content on the page impacts the acceptability of a message. As a general guiding principle, content on the described landing page would need to meet patient, HCP, and DTC regulations (i.e. it would be subject to the applicable sections of the Food and Drugs Act and Regulations, Health Canada policy documents pertaining to consumer advertising, and the PAAB Code).

Hey @smurcar We cannot provide a review over the forum. Claims around the approval process are generally restricted to factual statements about the current state of the approval. Note that it is not acceptable to promote the approval process in branded advertising per Food and Drug Regulations C.01.007. See this previous Q&A. In reference to the sticker approach, we suggest submitting an opinion with the content you intend to use and the positioning on pieces (with examples) so that we may assess in the context of a complete picture. Given the outlined copy provided, it appears it may be appropriate to use a sticker to update pieces. The full review would cover the requirements for the copy on the sticker and the copy which would become covered on the revised pieces. We’d also need to assess if anything else changed in the TMA that may affect the piece beyond just the NOC status change.