This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”. Let’s look at a few examples of where it would not be acceptable. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph. If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

Thank you so much for your response!

Hey @ALee Please see Q&A 223 & Q&A 713. These were found by searching “ongoing”. If you select “in titles and posts” you may find additional past questions relevant to your question.

Hey @ALee The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

Hey @mimi77 Yes. It would be considered discussion of drug therapy or content relating to drug therapy.

Hi @Jennifer-Carroll , thank you so much for confirming!

A sale representative may leave a physician a full, unedited copy of a published, authoritative consensus guideline for a given condition. Please see the linked document on “What constitutes current medical opinion and practice?”. Depending on the nature of the visit, please also be reminded that distribution of material by a sales representative may constitute an act of advertising and should adhere to the advertising regulations, e.g. product specific guidelines on off label use would be a violation of the regulations.

Good Morning @Jennifer_CM Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).

Jennifer, thank you very much for your prompt answer. We will do that.

Hey @GMC This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".

Hi @caitlinbyrne When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.

@jennifer-carroll Great, thank you!

@jennifer-carroll said in Imagery: which exceeds name, price, and quantity, this copy should be blurred to prevent advertising to the general public. Thank you!

@jennifer-carroll Amazing, thank you so much!

@jennifer-carroll Thank you very much for the very comprehensive and helpful response!

Hey @cchristopoulos Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.

Good Morning @alee What a great question. This one got us thinking. We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.

Hi @alee A non-inferiority test that results in a "statistically non-significant difference" is a form of statistical analysis and would be required to support such a conclusion, and it is not appropriate to conclude non-inferiority (or similarity) based on nonsignificant test result in a study designed only for superiority as noted in the Guidance Document for Claims Based on Non-Inferiority Trials. The appropriate interpretation of this observation is that the test product failed to achieve statistical significance for superiority (i.e. it would not be considered a “positive clinical outcome”), which does not support a claim of “similarity”. Please also note that all clinical claims must be pre-defined, directionally consistent with the primary endpoint (confirmed through statistical evidence), and similar to the description in the domains section, overall scores require statistical significance as per sections 3.4, 3.5 and 3.6 of the Guidance document for the Use of Patient Reported Outcomes in Advertising, respectively .

Hey @laraholmes All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.