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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