Author : Mon CMPQ

800

Product name on sales business cards If the product name appears with a message which identifies a therapeutic area, it would prompt the inclusion of the indication and lowest level fair balance. If there are no claims or copy on the business card which would suggest therapeutic use, it would likely be acceptable. Question 280 […]

799

Hello, I’ve had a launch announcement PDF file approved for e-mail distribution by PAAB. If I want to send this exact same file via fax, do I need to get it approved again by PAAB? Thanks. If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as […]

798

Is the following service exempt from PAAB review, as we think it does not meet the the criteria for a promotional activity. A pharma company would use a vendor to include a link to a peer-reviewed, on-label, full publication for their approved product, on a website other than the journal in which that publication was […]

797

Hello, I work at an agency and one of our clients is considering a website for patients enrolled in their PSP. This website would be DIN gated at which point the patient can create an account using their email address. The patient would then receive a confirm profile email with a link to create a […]

796

Further to response to question 726, the FDA in the US has issued Guidance on Medical Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers. This approach outlines that information about long-term safety/efficacy of products approved/cleared for chronic use may be considered « consistent with » the FDA-required labelling, if features of the use […]

795

Our corporate logo has recently changed. We would like to swap out our old logo with new one on digital assets that are PAAB approved. Do we need to notify PAAB as an FYI? Does this invalidate the approval somehow? Thank you. It does not invalidate the pieces. The transition of the corporate logo can […]

794

For communications of « contextual use of a product name », that doesn’t require preclearance, does it have to fall under the 5 criteria identified in section 1.5D of the code or does it simply not have to have a therapeutic claim or a promotional claim. ie. Does the statement « Call XXXXX for samples of product Y » […]

793

Hi there. I submitted a question a few weeks ago regarding whether PAAB needed to review market authorization announcements that do not include any statement of the indication, however my question was not answered, so I am asking it again: Under the PAAB code, it is clear that under section 1.5(D) that a formulary announcement […]

792

We are currently waiting for approval for a new indication. Is there any way to disseminate unbranded disease information concerning this new indication before approval (ex: head office emails, medical emails, banner ads, etc.)? Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.

791

Hi there, I hope you are doing well! I’m wondering if an association/organization such as SOGC writes a letter endorsing a tool if that will suffice as an acceptable reference to support statements made in the piece. For background, our product has two indications but we do not have a study that supports both equally […]

790

We are creating a clinical trial recruitment piece directed to patients evaluating the use of a marketed product for a new use. The study will evaluate the use of our product in combination with another marketed product and the inclusion criteria include the use of prior agents. To improve patient comprehension of the study and […]

789

To a currently marketed product, and instead of a « now available » message, the message is «  has been granted market authorization for additional indications »? (Again, with or without a link to the updated PM Hi There. I’ve seen several questions that have circled this issue, but none that have addressed it head on: Is an […]

788

Hello Are branded and help seeking search engine marketing campaigns allowed to run simultaneously if coming from different ad accounts and going to different landing pages? If the regulations are followed, there would be no cross over between these two campaigns as the branded campaign could not include mention of therapeutic areas and the help […]

787

Hi, when Patrick Massad started as the Commissioner, he mentioned at a conference that PAAB will be able to approve/comment for websites projects using a wireframe / blueprint tool provided by agencies, removing the need to comment on pdf and thus making it easier and quicker for everyone to share and implement comments. Has this […]

784

When constructing Fair Balance, under « Other relevant warnings & precautions, » are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category. When it […]

782

We have a product with a complex indication, requiring previous treatments, biomarkers, etc. We would like to create an algorithm that depicts the approved indication within a diagnostic/treatment framework. Can we utilize Guideline pathways (not recommendations) in order to put the indication in a larger clinical context? For example, we would depict the entire Guideline […]

781

We have a product with an open indication (Product X for the treatment of Condition Y). Guidelines now suggest the use of Product X in combination with another product. Can we promote this combination in the context of Guideline recommendations (ie. not showing clinical data/claims)? The presentation would be assessed to evaluate consistency with the […]

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