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.
Efficacy Claims & footnotes
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For efficacy claims in promotional pieces, what is the minimum requirement of support required? Can we footnote the supporting data or lead the user to the HCP website where the complete data information can be found?
Or if we include a softer efficacy claim for a product will a CTA to the HCP website suffice?
Thanks
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For efficacy claims in promotional pieces, what is the minimum requirement of support required? Can we footnote the supporting data or lead the user to the HCP website where the complete data information can be found?
Or if we include a softer efficacy claim for a product will a CTA to the HCP website suffice?
Thanks
Hi @joao-borges
Thank you for your question. In general, Code section 3.1 provides direction on requirements for substantiation. Please also see our resource link for types of marketing benefit claims and tips for levels support for each type.
The efficacy claim itself determines whether supporting information is required to appear prominently in the body copy of the APS (rather than a footnote). Linking to an HCP website with the data is generally not acceptable. For fundamentals on substantiating claims and other topics, we also suggest our new PAAB 1.0 training course.
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Hi @joao-borges
Thank you for your question. In general, Code section 3.1 provides direction on requirements for substantiation. Please also see our resource link for types of marketing benefit claims and tips for levels support for each type.
The efficacy claim itself determines whether supporting information is required to appear prominently in the body copy of the APS (rather than a footnote). Linking to an HCP website with the data is generally not acceptable. For fundamentals on substantiating claims and other topics, we also suggest our new PAAB 1.0 training course.
@jennifer-carroll Thank you this was very helpful
