We are exploring the use of a 5 year extension study in branded APS that is not included in the sponsor’s TMA. This is an extension of the original study included in the sponsor’s TMA. If the only methodological discrepancy from the initial pivotal trial is that the primary endpoint of PFS in the extended […]
This question relates to PAAB code 3.2.3 (information on ongoing trials) Q1: Can you please confirm the elements that can be included in an APS – Study design, objectives, endpoints? Q2: We are assuming that when the code states ‘ongoing’ it means prior to an NOC which includes a trial that is no longer recruiting […]
A primary endpoint is stratified by multiple parameters, as stated in the TMA. Would it therefore be acceptable to include the subgroup analysis results for these parameters in advertising (Forest plot) from the published study, assuming they are statistically and directionally consistent with the overall primary endpoint result? There are many considerations in the assessment […]
Product name on sales business cards If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as an FYI for assessment. See also Q&A 650.
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 […]
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 […]
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 […]
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 […]
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 […]
For how long can the word “new” or saying “now approved” can be used in promotion to announce a new prescription drug ? Please see question 423.
Hello PAAB! I’m working on an unbranded piece that’s for HCPs. It discusses the impact that medication adherence can have on efficacy for a specific class of drugs. Being relatively recent, my brand’s drug is not discussed in most of the trials that evaluated the link between adherence and efficacy for this class of drug. […]
I know that an on-label reprint distributed in a promotional context (ie by a sales representative) needs to conform with the PAAB Code, but does it need to undergo PAAB review? Dissemination of full, unedited articles from medical or scientific journals whose peer-review was steered by the publisher’s editorial board are exempt from PAAB preclearance […]
I am hoping that you can help provide us some guidance with respect to the use of “Now on Formulary” stickers. It is our understanding that such stickers are exempt from PAAB review as long as they are not linked to a therapeutic message in any way as per Section 6.6 d(ii) of the PAAB […]
Why is it that medical devices do not undergo the same scrutiny (PAAB approval) as prescription medications with regards to promotional tools? The scope of the PAAB code currently excludes healthcare products approved by Health Canada as medical devices. The MEDEC Code of Conduct applies to such advertising. You can send complaints on medical device […]
Do different guidelines exist for promotion of OTC brands to health care professionals with respect to the following: comparison of different products based on the approved labelling for parameters such as indications, and the non-clinical claims such as taste,color, odor, dissolution. Section 5.10.2. of the code does not distinguish between Rx and OTC brands. use […]
Can a cover tip ad cover the complete front cover of a medical journal? If not, what is the max. percentage? The PAAB does not rule on the maximum size of cover tip ads. Contact the publications as they may impose such restrictions.
Dear PAAB, I’m reviewing a Dear healthcare professional letter to anounce a new packaging of a product. the letter is one page but our standard balancing information in arial 10 font is one page and a half, which is longer than the actual anouncement. I was wondering if it is acceptable to keep the indications […]
What type of guidance is there regarding the inclusion of product pipelines in Canadian corporate websites? Promotion of a drug prior to market authorization would contravene Section C.08.002 of the Food and Drugs Regulations). Note that one also needs to consider the consumer regulations as corporate sites are open to the general public. Given these […]
Are printed PI pages still required for journal print ads, or can a web site be given within the ad directing the reader to the PI? Assume that claims are being made within the ad. Thanks Printed PI pages are still required. Please refer to PAAB code sections 6.1, 7.1, and 7.3. The current PAAB […]
Dear PAAB: We have a HCP-directed APS for a congress announcing “Company A name” and “Product B name” are “now here” in Canada. An offer to “visit at Conference Booth XXXX” is included. There are no further product / therapeutic claims. Is this exempt from PAAB preclearance review, as per the “now available” exemption in […]