Miscellaneous

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 […]

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 […]

713

Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials. […]

710

For Help-Seeking Announcements, the Distinction Between Advertising and Other Activities states “there is no implication that a drug is the sole treatment available”. Does this mean no implication for a single brand within the context of available drug treatments, or no implication for drug treatment over non-drug treatment? The Health Canada Distinction Document has the […]

692

In DTC would non-medical devices (i.e. Breezhaler/Respimat/Ellipta) be associated with their drugs immediately? As such be limited to the name, price and quantity in terms of messaging or would there be leeway to talk about device features in a comparative standpoint or would that be against the code? Please see Ask PAAB Question #500 (search: […]

693

Is a non-medical device associated with a drug be recognized as a therapeutic product regardless of whether the ad in question contains information about the drug itself in a direct to consumer standpoint? Yes. Please see Ask PAAB questions #560, #528 and #500 (search: Device)

700

Can we present two different brands, (which are two different therapeutic areas) in one APS (i.e. in a LB) as long as the indication and balancing info is presented for both brands? The co-promotion of different products within a single APS is possible, even for different therapeutic areas. The key is that there is a […]

684

When two companies are co-promoting a product and using the same material approved by PAAB, are the promotional materials required to display both company names and/or logos or can the material have one company name and log and still be used by both companies? The co-marketing of a product and identification of one or both […]

676

Hi Patrick – Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)? Hello. The rationale for section 3.7 is that different formulations could cause products to have different properties. One should not assume that two product […]

659

As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: “Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years”. It is our understanding that for any APS we are limited to one year of usage of […]

639

Just wondering how long it would take to receive a response to a question submitted through Ask PAAB? Good question. AskPAAB provides us with a mechanism to provide answers to anonymous questions in order to educate the entire industry about general aspects of our Code, our guidances, and the regulatory framework.  It is not intended […]

621

Has the PAAB ever considered providing review comments as annotations on submission documents, rather than an itemized review letter? This would seem to save both PAAB and Clients time. This was considered when we first created the eFile system for the very reason you suggested. On the surface, it appears to be a good idea, […]

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