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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
488

What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)

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487

Hi PAAB, would product related messages posted on the intranet of a company for employees' information be considered direct to consumer advertisement, given that the intranet is accessible to any employee of the company but not to people from the outside? Thank you!

486

Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!

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485

If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?

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484

What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?

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483

In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?

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482

Is it acceptable to use Data on File such as a PSUR to support non-clinical statements such as patient exposure? If so, what format should the Data on File take as it is not possible/desirable to provide the whole document as data on file. Thank you.

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481

Is it possible to refer to CME content on a web site in an unbranded email to HCPs?

480

Is it possible to link a site with CME content from a gated, branded website? If so, is it possible to identify the tab as leading to CME content? Would it be possible to link to a CME-containing site using an interstitial page/disclaimer between this site and a branded website?

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479

According to section 7.4, it sounds like Canadian corporate websites need to be reviewed by PAAB. However, I have not come across any that have the PAAB logo. Can you please clarify? From a previous Q&A it sounds like corporate websites have to be written with consumer regulations in mind too since they are publicly accessible. I guess that means we cannot have a write up on the therapeutic areas on the corporate website because that would be linking the therapeutic area to the product, because the product info would be found in the Product Monographs that are linked to the site. Can you please clarify this for me? Thank you!

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Commissaire adjoint  

Patrick Massad
Commissaire adjoint

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