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341 - If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.
• Jennifer Carroll -
319 - I am confused on how Section 6.6vii is different from Consumer Brochures in "The distinction between advertising and other activities". The only differences I can think of is audience (patient vs. consumer), branding (branded vs. unbranded) and treatment discussion (no mention of treatment vs. objective discussion of all available treatments). Am I on the right track? Thanks!
• Jennifer Carroll -
287 - PI, when required or when necessary, must form an integral part of the advertising message, which may be accomplished via a reference to a website link in a printed piece or by a direct electronic link to a website. If I am reading this correctly, as long it is placed on the ad page where they can find full prescribing information, I do not have to include prescribing information with my publication. Thank you
• Jennifer Carroll -
263 - Has the PAAB ever considered a "priority review" stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission Coordinators could limit Files to those of formulary/safety content, or those of shorter length.
• Jennifer Carroll -
259 - Are there any guidelines (outside of color preference) for placement of the PAAB logo on an approved piece? Is there a size limitation of the logo or a desired location (front vs. back side) we should consider? The website is not loading the PAAB logosheet PDF unfortunately?
• Jennifer Carroll -
254 - I'm curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn't this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also has DTC ads and posters in addition to the website.
• Jennifer Carroll