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.
446 - Can you confirm whether Code sections 2.10.1 and 2.10.2 are mutually exclusive? For example, could an abbreviated indication appear with the first marketing claim in an APS, with the verbatim indication appearing elsewhere in the APS?
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2.10.1 and 2.10.2 are not mutually exclusive. A statement conveying all boundaries of patient selection must be presented among (or prior to) the first set of marketing benefit claims in the APS. This statement may be the verbatim indication (thus satisfying both 2.10.1 and 2.10.2), or it may be some other statement identifying all boundaries of patient selection in an alternate format (e.g. “Only use drug X in patients who…”). In the latter case, the verbatim indication must still appear somewhere in the piece. Additionally, use of the statement “indicated for” should be restricted to the verbatim indication. Refer to the PAAB guidance document “Guidance on indication placement in advertising” for additional information.