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  4. Product Monograph Comparisons

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

  • Correct any misunderstandings
  • Provide guidance when questions remain unanswered after a few days
  • Support discussions where official clarification is needed

Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.

Thank you for being part of the conversation.

Product Monograph Comparisons

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  • L Offline
    L Offline
    Lags
    wrote on last edited by
    #1

    We understand the guidelines regarding what can and can't be included in a PM comparison of several products. This question is limited to the products included in the comparison. Let's say the table is a comparison of a specific drug class with the same indication and that there are about 10 products on the market. What does PAAB require as support that some products do not need to be included in the table? What are the guidelines to determine what products need to be included in the comparison and what products can be excluded? Or is at the discretion of the manufacturer developing the table?

    Jennifer CarrollJ 1 Reply Last reply
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    • L Lags

      We understand the guidelines regarding what can and can't be included in a PM comparison of several products. This question is limited to the products included in the comparison. Let's say the table is a comparison of a specific drug class with the same indication and that there are about 10 products on the market. What does PAAB require as support that some products do not need to be included in the table? What are the guidelines to determine what products need to be included in the comparison and what products can be excluded? Or is at the discretion of the manufacturer developing the table?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @lags

      This is a complex question that would be better suited as an opinion submission where details on the therapeutic area, class of products, proposed inclusion and exclusion criteria etc. could be provided. It is not possible to create an exhaustive list that would be clear enough to apply across all therapeutic areas. As a general response, any selection criteria that have eliminated other products from the presentation, should be clearly conveyed along with disclosure to the audience that this is a selective presentation.

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      The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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