Hi @gmc We have reviewed such sites. In general, the URL for the website (brand.ca) is to the homepage where gating can be started with the DIN number for the patient to enter. Once the patient is in the site, part 3 of the Product Monograph will dictate whether patients can see other therapeutic areas/ indications, i.e. is there only one part 3 for all indications or separate part 3s for separate indications? (we refer you to Section 1.1b of the Guidance on Branded Patient Information). If they are separate part 3's, then one suggestion is for the site to offer an option for the patient to enter their indication in order to enter the appropriate section.

Hey @mbos There are a few regulatory issues that must be considered. For example, the approval process must not be discussed in advertising per C.01.007 of the F&DR. Another issue is that one cannot convey a message that implies a Health Canada endorsement/recommendation. We could consider a message which is factual such as “the indication of Product X has changed from NOC/c to NOC”. This message should be presented in a manner that is separate and distinct from other messages (e.g., pivotal trial data that may or may not be the basis for the change).

@jennifer-carroll said in Defining "data gathering is complete" for trials: 1.8 Thank you!

Good Morning @ey Yep. This can be done as a template file. As long as all the aspects of the gate are universally transferable across the websites. In the template submission, you’ll want to be clear about the intended use so that any potential issues can be raised prior to approval. In the website submissions, please ensure you cross-reference to the template submission.

Hey @maryssa In theory an "only" dosing claim can be made. The specific claim and/or copy required would be assessed during the review based on the indication and limitations of the "only" feature. Yes, a disclaimer is required when making a non-clinical claim. In this example the copy is inherently comparative against the dosing of all other products. The disclaimer would be required to read something similar to “Comparative clinical significance unknown”. The extent of the dosing copy will be dependent on the dosing in the TMA, the overall message of the piece and any class features which may impact the interpretation of the claim. In general, you will also require copy reflective of “for full dosing and administration, please see the Product Monograph”. A letter from medical/regulatory confirming the nature of the “first” and/or “only” claim. The sponsor should also recognize in that letter, that they are aware that it is their responsibility to pull all pieces with this claim from the market if it should no longer be true, regardless of time left in the approval window.

Hello @karen-taylor The terminology “HCP/patient interaction areas” was used to be a broad and all-encompassing term to include the office, waiting room, digital space etc. where the HCP has control over the content that is in the space. PAAB Q&A 240 provides additional clarification.

Hey @danielle If the leaflet was produced by the third party developed patient app, and there were no implications for outcomes which could be associated to the brand, it would likely not require PAAB review. As an example, an independent third-party medication reminder and adherence tracker's promotional leaflet which spoke to the features of the app would likely be exempt. If that leaflet contained outcomes that could be expected, improved etc. as a result of proper adherence, this would likely not be exempt. PAAB can provide an opinion through the opinion service if you’re not sure if the leaflet would fall into this category.

Hello @taylor-murphy You raise some excellent questions. The difficulty in setting these types of standards is that nabiscos/eyebrows/corner callouts are vastly different across pieces. They are impacted by the prominence, positioning, content on the page, content in the nabisco, presentation of other copy on the page, presentation of copy throughout the piece, design elements for the brand/on the page, and so on. They are often used to create separation between clinical and non-clinical. General guidance would be that it has to look separate (if this is the purpose of the feature). If it looks like the headline for a piece, takes up ½ or even a third of the page, is integrated into an image, etc. then it’s likely not creating separation. We’re happy to discuss what could be proposed as guidance. We invite the Forum community to post some ideas below.

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.

Good morning @gmc Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.

Hello @hannah There is insufficient information to determine if the data would be considered off-label, but there is sufficient information to determine that it would not be acceptable data as post-hoc analyses are not considered high quality evidence. Per code section 3.1.1, clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. As the data on file in this case is not in the TMA (PM), it is not acceptable for advertising claims.

Hello @natbourre Patient organizations generally package complex information in a manner that is more easily understood by the general public. HCPs should be directed to information that was written with a higher complexity intended for more specialized consumption like recognized healthcare professional organizations or medical textbooks. A statement referring to the sheet would need to be clear that it is for consumers or is patient information not designed for healthcare professionals. PAAB would need to assess the linkage to ensure that it is not overtly off-label.

Good afternoon @gmc The form is not exempt as service oriented messages to patients/HCPs are still subject to review. See FB on PSP enrolment forms for related information.

Hello @gmc No. This would not meet the specifications outlined in Guidance on Generating the Three Levels of Fair Balance

Hey @tmcm Yes, a compliant unbranded disease information pieces/tool could be created to be provided to patients by healthcare professionals. Patient information should be supported by consensus groups and authoritative sources. Guidelines are considered an acceptable source for disease targets in an unbranded patient piece.

Hello @tmcm If the visual does not allude to therapeutic use then it is likely exempt. Note that when you link exempt content to advertising, the exempt content may no longer be exempt. If the booth contains promotional claims, it would be prudent to convey in the review of the booth, the content of the conference banner which is directing the user to the booth so that we may ensure it does not exceed the regulations.

@tmcm Thank you for your question. The proposed APS does not meet exemption criteria as per Code section 1.5. It is considered a promotional message and would require PAAB review. As an advertising message, bolding may be possible depending on the context. The appropriateness would be determined during the review process.

Hello @Lags The question above was interpreted as requesting clarification of the regulatory classification of the studies. While it did not specifically state that disease Z study was “ongoing” (the definition of this is critical – see below) , there are scenarios where an ongoing off-label study may be presented in APS, as well as scenarios where it must not be mentioned in APS. For further details of the discussion of ongoing studies, please see Code section 3.2.3 as well as Q&A 223 & Q&A 537 If the studies no longer qualify as ongoing (no longer in the data gather phase, or an interim analysis has been performed, data has been presented, etc.), the study cannot be discussed as it is considered off-label. There should be no pre-NOC advertising or off-label advertising. The crux of 3.2.3 is that it is non-promotional and intended only to outline the research the company is involved in.

Hey @tmcm The challenge with this copy is that you are forecasting future events. It is not acceptable to promote a milestone prior to achieving that milestone. We would recommend something similar to “Over 34 years of experience in Canada".