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.
Implications of updated safety information in Product Monograph
-
Hello,
The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?
-
Hey @JDilly11
Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.
