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.
Unbranded disease mechanism APS for first-in-class product
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If a product has been recently approved with a novel mechanism of action that targets (for example) a unique signalling pathway, is it acceptable to create an unbranded HCP-directed mechanism of disease APS that focuses on that pathway?
Or would that inherently brand the APS as there is only one treatment available targeting that mechanism of disease?
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If a product has been recently approved with a novel mechanism of action that targets (for example) a unique signalling pathway, is it acceptable to create an unbranded HCP-directed mechanism of disease APS that focuses on that pathway?
Or would that inherently brand the APS as there is only one treatment available targeting that mechanism of disease?
An unbranded APS may be created for physiology or pathophysiology of the signaling pathway. However, the APS may not make reference to potential treatment or exogenous intervention at the target site as that would brand the APS if there are no other agents that work at that target.
