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    698 - Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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    • Jennifer Carroll
      Jennifer Carroll last edited by

      Let’s assume that we’re talking about claims in HCP advertising. Pieces which include direct or implied claims (including the product indication) are subject to PAAB review. In fact including the indication would prompt the requirement for the lowest level of fair balance. This applies regardless of the imagery included in the piece (although imagery may result in middle or highest level fair balance being required if it alludes to other claims).

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