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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
589

Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks!

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588

I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is US-developed (independent of Canadian input) and presented to a US-Healthcare professionals audience only, is the material developed subject to PAAB review? A few mitigation steps would be in place: • All learning event promotional tools (such as the invitation) will state that Canadian physicians and any Canadian healthcare professionals (HCPs) will not have access to this event. • A check-in safeguard system will be set up at the entry of the event (such as checking and scanning the badges) to ensure access is only granted to US-HCPs. • A disclaimer will be included at the bottom of each slide of the presentation clearly stating that all information is based on the US prescribing information • The local internal review team will review and attest to the presence of this disclaimer before the slide deck can be used at the event. Thank you in advance.

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587

Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks

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586

If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.

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585

Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?

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584

Can you please explain why a claim of "Guidelines recommend..." can only contain the generic drug name, vs. brand name? Would it make a difference if the Guidelines themselves link generic and brand names?

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583

A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.

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582

Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among ALL patients)?

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581

For an efficacy claim, comparing head-to-head results of the study drug vs. the standard treatment, what support is required to justify the claim "significant"?

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580

Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Have a great summer and see you in September.