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285 - Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!
• Jennifer Carroll -
284 - Hi Patrick! We're looking to collect data from a patient survey related to dosage and administration. Ultimately, we would like to disseminate this information to HCPs so they are more aware of their patient behaviour and preferences in relation to their treatment. Could you suggest a way we would be able to do this? Thanks
• Jennifer Carroll -
278 - In an APS for a prescription product, if you want to present side-by-side comparisons of non-therapeutic information from Product Monographs (e.g., product properties, use limitations) as per section 5.10.2, do you need to include all of the approved products in that indication or is it acceptable to show only selected products (e.g., two out of five available agents)? If all products must be mentioned, does that also include generics or only branded products? Thanks!
• Jennifer Carroll -
273 - Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we don't make mention of them in the APS?
• Jennifer Carroll -
265 - Please explain "Claims relating to PRO endpoints must appear clearly within the context of the Health Canada approved indication." Does this mean that data from PROs must be in the PM, or just that the PM must address the outcome being assessed (e.g. "Drug X treats condition Y, and the pain from condition Y", for the PRO of pain reduction).
• Jennifer Carroll -
213 - Dear PAAB, I am curious about creating unbranded educational material around Subsequent Entry Biologics. We know that there are potentially a lot of issues that SEBs can have considering the nature of the manufacturing process. Is it acceptable to educate physicians on the challenges, risks, and non-identical nature of SEBs vs. orignial product, using review and 'expert opinion' articles in an unbranded piece? Alternatively, if we had a study that was done that showed these issues would we be able to use that? Or is it, if Health Canada has approved it then we can't say anything to infer challenges and risks? Many thanks.
• Jennifer Carroll -
191 - I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")
• Jennifer Carroll -
131 - I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.
• Jennifer Carroll