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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
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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577

Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.

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576

We are in the process of developing a tool that will highlight a product's reimbursement program. It would state "reimbursement navigation assistance available for Product X" and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly to the manufacturer. In addition, this tool would not include any product/promotional claims, only the name of the product would be mentioned. Given that messages limited to name and price are exempt from PAAB review, would "reimbursement navigation" also be considered exempt? If not, is there any way to make this tool exempt?

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575

Our question is related to question no 70 which was: "The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks

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574

I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website to PAAB review?

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573

Hi, Is it allowed to develop a tool for physicians that will be used with a patient to help the patient make the decision to use a specific therapy? if yes, should the information in this tool restricted to Part III of the PM only or other sources are also allowed? Thank you!

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572

As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?

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571

Are Naturopathic Doctors included in the definition of 'health care practitioners' when determining whether promotional material needs to be reviewed by PAAB?

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570

Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.

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