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Hello @dmauri PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.

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).

Thank you @Jennifer-Carroll!

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

Thank you @Jennifer-Carroll. This is very helpful!

Good Morning @Constance PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.

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".

Hey @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

Good Morning @HollyMed Pooled data is not acceptable even if part of a pre-planned long-term extension study.

Hi @dmauri This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.

Apologies for the delay @SMurcar. We were in the process of upgrading the forum over the last two days. As the piece would be moving from two sided to one sided this would change the flow. The content in the top section may set context for the bottom section depending on the formatting and flow. We would suggest submitting for a minor update (if the resizing is intended to replace the small postcard altogether) so that we can assess the revised visual flow to ensure all aspects of the Code remain met. The addition of the QR code as described above could be considered as a minor update. Please see the Submission Guidelines for more information

Hey @cscholes We understand that LinkedIn is an ungated platform and open to consumers. As such, the site is subject to consumer regulations similar to PF question 458 and is highly restricted for prescription advertising. Targeting to HCPs within the open platform may not guarantee that consumers won’t see the ad as well. Please also see this linked PF question and our Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets and subsequent clarification document Gating Mechanisms for HCP Digital Assets (designed in collaboration with Health Canada) regarding HCP validation. How HCPs are identified and verified, the nature of the targeting and how well it can limit the audience to only validated HCPs would be information that is required as part of the review process. PAAB will provide advice and direction based on the Health Canada DTC regulations, the PAAB code principles and the information that the sponsor can provide for the restriction of the intended HCP audience within this consumer space.

Hey @mimi77 This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.

Hello @tk2022 It appears that you are asking for an exempt review over the forum. Please note that this is not the intention of the forum. From a search it appears that you are taking the term “simple sample” from Question 47 or 58. If this is the case, please ask the question under the relevant Q&A in the future to help maintain the usability and clarity of the Forum. Q&A Solicit product samples should provide sufficient information along with the referenced questions within that response, to assess “simple”. When unsure, please be invited to submit for an opinion.

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.

Hi @hollymed Please see this PAAB Forum Q&A

Hi @chagali-toney-0 Per the Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc “3. For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted.” Please note that this does not state “verbatim”. However, it should be interpreted to mean that no data from outside of the PM can be presented.

@jennifer-carroll Great, thank you!