If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to […]
Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself? Mention of a study in the PM bibliography has no influence on the PAAB review. PAAB code section 3.1.2 states that citation in the bibliography section of the Product Monograph […]
If you are creating a Pt Booklet based on Part III of the Product Monograph, can you also include a patient-friendly description of the primary efficacy outcome? If so, how about primary and secondary efficacy outcomes? Product content is limited to that which appears in part III of the PM. Unless the study endpoints are […]
In the current consultation by Health Canada on the Guidance Document: Product Monograph Release Part I: Health Professional Information and Part II: Scientific Information, Health Canada proposes to remove references, as per the response to Question #309 , what impact would removal of references have on the utilization of the study by companies if not […]
We have an HCP-gated educational website/app containing endorsed medical education. We would like to post a program comprised of KOL-presented patient cases containing a video segment featuring one of that KOL's patients. What is the patient allowed to speak about on the video (e.g. their quality of life post-therapy…)? First you have to decide if […]
Are promotional materials for class II medical devices required to go through PAAB clearance? No. Please refer to PAAB code section 11 for the definition of healthcare product as used specifically within the PAAB scope.
Are notes to HCPs allowed to be attached to PAAB material or approved studies. If not, where is this referenced in the code. PAAB approved ads should be used exactly as approved otherwise it’s not really “preclearance” (e.g. without modification through inclusion of additional notes affixed to the piece). Affixing notes to independently generated materials […]
Would a corporate message similar to « Company X is committed to research in prostate cancer » be PAAB exempt? On its own (not linked to anything else), this statement is a corporate message without product mention. It is therefore exempt under s6.6(v). Please keep in mind that Health Canada is very concerned about pre-NOC product messages […]
I am curious to know how/why the product ColdFX can make DTC claims such as 'clinically proven' and '#1 doctor recommended'. Would this not fall under the NHP regulations of PAAB? Thanks for your question. There is an important distinction to make here with regards to the Canadian regulatory landscape for drug advertising. The PAAB […]
If a pharma company is developing a brochure that includes general information about clinical research to better educate patients who might be considering participation in a clinical trial, is PAAB (or another regulatory body) required to review and approve the brochure? Please note that this resource would not be developed for use during a specific […]
I am interested in PAAB training. How can I achieve this training? Contact Reviewer/Trainer Jennifer Carroll by calling the PAAB office (905-509-2275).
Hi there, Is the full article needed for the references or is the abstract okay if the content of the reference is there. Thank you, Anne The full peer-reviewed article is needed. For example, we need to assess the context of the statement within the reference and, where relevant, we need to assess the methodology.
I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only « on-label » information, and further provided the […]
We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page […]
What type of references are allowed in unbranded materials? I am interested in using studies which are based on patient surveys/questionnaires as well as some review papers (neither of which have a focus on the company's branded product). Would these type of references be allowed or are strictly limited to the same rules as branded […]
Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, […]
I am developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Do you have any recommendation as the where to purchase a list of valid license numbers? Thank you. As PAAB is an impartial preclearance body, we cannot endorse specific service providers. We cannot […]
May we: Report the results of a patient satisfaction study to doctors? Ask doctors' opinions of key results from of that study? Then report back to all doctors a summary of responding doctors' aggregate opinions? In principle, this is possible for satisfaction messages relating to (and limited to) specific product attributes for which surveys (conducted […]
I am a journalist doing a story on what advertising and or perqs are allowed to be given to doctors and medical professionals to use/prescribe a drug. What regulations are in place governing what is aimed at the medical professional? Hi. I am responding in Patrick’s absence. The PAAB website has a wealth of information […]
I would appreciate clarification of the Explanatory Note for 6.6 that says « Now on provincial formulary » (or equivalent). Does « or equivalent » allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the […]