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Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.

Questions et réponses les plus récentes
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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579

When a disease is very rare, there is often no published Canadian specific epidemiology or incidence studies. What is PAAB's position on allowing a simple statement that the disease is 'rare'?

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578

Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general information regarding disease state. Do we need PAAB approval or ASC approval alone is sufficient?

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Patrick Massad
Commissaire adjoint

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