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.

@jennifer-carroll said in Unbranded APS on clinical study summary: ly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three Thanks for the clarification!

@jennifer-carroll Wonderful, thank you.

Good Morning @kshulist In general terms, the linkage would have to be assessed to determine its acceptability. While it may appear to be less of a concern linking unbranded to unbranded, the linkage would be assessed during the review process where additional guidance could be provided in the context of the specific tool/message. There are scenarios where a deep link is fine and where it is not ok. For example, deep linking to a page which focuses on the sponsor’s product, even if it’s third party generated, from a sponsor generated unbranded APS, would not be acceptable. Apply general linkage principles to ensure that you are considering both the regulatory audience and content being linked.

Hello @kshulist This answer is provided with the understanding that the nominal p-value is not in the product’s TMA. The application of the above would depend on why the p-value was nominal. It can be from different reasons and the nominal p-value may become a meaningless number if the assumptions of the statistical model used to compute it do not hold. Violating any of the varying prerequisites of a significance test might render the nominal p-value not acceptable. As such, the ability to present the data and the potential types of claims in an APS would require consideration of the statistical analysis. For the example in question, if a statistically significant p-value is nominal simply because it was unadjusted, a claim neutral presentation could be considered per the prior Q&A.

Hey @user123 Please see Q&A 674

Hey @kshulist As per the principles noted in Q&A 508, if the published paper conveys a statistically significant improvement in the absolute risk reduction for the response rates (with multiplicity adjustments performed when required to manage risk of type I error), the NNT may be calculated.

Hey @ap An unbranded piece that speaks to products which the patient is not on, would be considered consumer advertising. The activity above appears to fall under “Medical condition and treatment awareness material” (formerly consumer brochure) and as such would have to meet the requirements outlined in the Distinction Between Advertising and Other Activities document under section “Medical condition and treatment awareness materials”. This outlines that all options must be included (pharmacological and non-pharmacological). The Product Monograph can be used as a reference for treatment formulation but would not support direct or implied comparative claims. The reference should not be listed in the piece as this would create a link between the brand and therapeutic use which is in violation of the Food and Drug Regulations.

Hi @vt, This appears to be about a specific product and class. We would assess on a case-by-case basis considering the totality of the market. In these instances, we suggest going through the review process.

@mimic909 Generally, when the route of administration is presented as a claim of product merit (e.g. promotional claims such as “convenient oral tablet” or “subcutaneous injection for at-home use”) in an email envelope (i.e. subject line/preview text), it requires fair balance (FB). Please see our "Tips and checklist" document. This principle applies regardless of the dosage form appearing in the proprietary/non-proprietary name (e.g. “PrDrug X (examplumab for IV injection)”.

Hi @constance Please see PAAB resource Provincial Formulary Coverage Statements Per the guidance document, the requirement for full formulary criteria disclosure is dependent on the nature of the claim e.g. inclusion of coverage codes requires disclosure of the full coverage criteria. Criterion are usually restrictions for coverage and act as qualification. Criteria generally do not require disclaimers if they are consistent and do not extend beyond the indication. Per the above reference, the indication acts as the limitations for initial consideration. There may be scenarios where disclaimers may be requested. This would be a case based assessment.

Hey @dmauri While it’s not an outright no, in the context of a branded HCP pieces a diagnosis should already have been made prior to consideration of the product. If a piece with differential diagnosis was to be considered, it would have to be overtly clear that it was to ensure the proper patient selection and there was no inference of off-label use. Ref: Guidance on Branded Patient Information [image: 1710278448434-7a4ab826-500b-4071-b0a0-9aa991f83f73-image.png]

Hey @alee No. There can be no mention of unauthorized products/investigational products as they have not yet received terms of market authorization. The discussion of ongoing studies is to demonstrate the company’s commitment to additional research of approved products.

Hey @constance The information from the TMA relating to each individual product promoted does not necessarily need to be visually separated into its own distinct module within a co-promotional tool though this does appear to be one approach that would likely satisfy the statement. In essence, there should be clear delineation between characteristics/features that pertain specifically to each product. When presenting a group of products’ indications and/or various data, it is important that they appear clearly separate from each other so as not to suggest combination use, additive effect or comparative claims as some examples. In addition, when presenting features of the products, switching back and forth, grouping or mixing presentations may create erroneous impressions or lack of clarity. It’s not possible to provide an exhaustive list given the variability between products, therapeutic classes, claims placement, headline/subhead positioning and emphasis, creative, etc. If this is in reference to a specific piece, we suggest submitting for an opinion or a consult meeting.

@jennifer-carroll Thank you Jennifer!

Hi @constance General enrollment based on geography may be considered when presented in a clear manner and with adequate disclosure of the pertinent PSP program information. For the highlighting of patient characteristics such as gender and age, acceptability is dependent on the balance of the APS content and supporting data as there will be subgroup emphasis considerations with such highlighting.

Hello @constance Similar to our response above, a description of the outcomes for assessment and the listed study information noted in your question, may be included in an APS in a non-promotional manner , prominently disclaimed for the off label uses, and also prominently labeled “Ongoing studies”, in a separate tab/page that is away from the promotional content of the APS. Please also see this Q&A 223 for additional information on the presentation of ongoing studies in a non-promotional manner.

Hey @kshulist An image that supports the evidence presented in the piece from an RCT, would be considered acceptable even if it was from a patient in an RWE trial. PAAB does not request confirmation that it is from a patient in the trial being presented who had the average response. The visual simply needs to reflect what would commonly be seen as “consistent with” the magnitude of effect demonstrated in the RCT. If the evidentiary basis of support is the RWE, use of the images would not be acceptable.