@jennifer-carroll I will do that. Thank you for your help!

Hey @elena A message of “talk to your doctor” or “talk to your healthcare provider” or “talk to a healthcare professional” can all be considered in both branded patient information pieces and branded direct to consumer (DTC) pieces as they are broad and all encompassing. When you state a specialty, there are implications. For branded patient information pieces, there will be considerations about the specialty that the patient is being directed to in the context of the brand. For example, we’d likely question “talk to your urologist” in the context of a cardiovascular product. This would be assessed during the review process. For branded DTC pieces, it would not be acceptable to specify a specialty as this would suggest therapeutic use in violation of the Food and Drugs Act.

Hey @llmktg The following response is provided as general guidance and should not be seen as an exhaustive list of considerations. Broadly speaking, when creating a branded patient experience video, remember that in a branded context, all content has implications for the brand. Also, keep in mind that patient-directed APS should be non-promotional, and HCP-directed APS should be supported by evidence meeting PAAB Code requirements. Subjective experience is often hard to qualify with blinded statistically significant data from randomized control trials. For a patient-targeted APS: Because a person’s experience is subjective, such a video may have promotional connotations, which would not align with section 6 of the PAAB code (see PAAB Q&A 450). It is possible to create a non-promotional video objectively highlighting the injection preparation + administration steps. A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”. For an HCP-targeted APS: A patient’s experience with the injection process is considered similar to a testimonial (s3.1.3). Testimonials that are consistent with data supported by acceptable evidence (see PAAB Q&A 703), may be considered. A branded video for HCPs may be created depicting a patient injecting themselves with the product, so long as it is objective, accurate, and complete (s2.1). A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”.

@jennifer-carroll Short and sweet, thanks Jennifer!

Hey @lora_nolan Yes, the mentioned guidance applies equally to new products as it would to established products. The pre-NOC submission pilot is not related to this update. It is an administrative guidance reflecting a process change where we moved from requiring final draft TMA and only accepting 2 core pieces prior to NOC, to accepting submissions for review at any stage of the TMA development and with no limit on number of files (at PAABs discretion). Please refer to the pre-NOC guidance for fees that may apply in addition to the standard initial fee should a TMA update be made mid-review of a pre-NOC APS. There is no difference from a Code application perspective in how a pre-NOC review is applied. The duration guidance also applies to pre-NOC submissions. Once a notice of compliance (NOC) is granted for a product, an APS for the product may contain claims noted in the study duration guidance that are related to “out-of-TMA updates” to TMA studies (these would be data from TMA clinical trials that are not mentioned in the TMA), if these claims and their supporting studies are consistent with the TMA, are pre-planned, published and peer reviewed, and do not pertain to NOC/c products or Class B opioid products. Section 1a of the guidance provides further details for this specific scenario.

Hello @natbourre The training speaks to an option for gating that would meet a sufficient barrier. The current methodology you are using (D.5 section of the PAAB Guidance for gating mechanisms) remains to be a valid gating mechanism. The guidance document provides additional options that would meet Code section 1.4.k.E. A gate should meet the standards outlined in the guidance which could be met by using a third party or in-house verification as one option.

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.