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.
Exemption for unbranded tool of single product within category
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If there is only one product available on the market within a particular category, would the tool be considered exempt from preclearance if the tool talks about the MOA of the category?
Natalie Bourré
Marketing 4 Health Inc.
Medical Marketing Consultant, Medical Writer
nat@marketing4health.net -
If there is only one product available on the market within a particular category, would the tool be considered exempt from preclearance if the tool talks about the MOA of the category?
Hello @natbourre
An unbranded APS can be considered exempt if it discusses only disease information without any mention of or allusion to drugs/medications/pharmacotherapy. Because the tool would be alluding to medication/pharmacotherapy via discussion of MoA, the APS would not be considered exempt.
