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Jennifer Carroll

Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.

Jennifer Carroll

Hey @mimi77
While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.

Jennifer Carroll

Hello @msargeant

Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Jennifer Carroll

Hey @HollyMed

Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.

Jennifer Carroll

Hey @HollyMed

Please see Q&A 593.

Jennifer Carroll

@Jennifer_CM
Example 3 appears to be about the product monograph web link destination. The original question above is about linking middle level fair balance to highest level fair balance. Linking middle level fair balance to highest requires that it’s within the same tool or directly attached. A print journal ad is not the same medium as a URL link (web based) and therefore would not be acceptable.

Jennifer Carroll

Hey @ALee
“Indirect link to a general formulary/Provincial homepage” is the same as “full formulary list of a province”. As per the response above, this would not be considered exempt.

Jennifer Carroll

Hi tk2022

Please see our more recent “Guidance on Real World Evidence/Data” for criteria and direction on the presentation of RWE in advertising to health care professionals. Please also see our "Guidance on the use of the Attention Icon" regarding unblinded data.

Jennifer Carroll

Hi @megancouture

Claims based on acceptable, authoritative consensus guidelines do not need to be verbatim from the reference. However, it must capture the recommendation accurately and within context. It must not impart a new or different meaning than the guidelines.

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