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.
Update of APS per new boxed warning in PM
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Can you please clarify what the manufacturer's responsibility is regarding updating approved APS when a new boxed warning has been added to a product's TMA? Does this need to be done proactively, i.e., materials updated prior to expiry? Or can they be updated as each piece expires?
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Can you please clarify what the manufacturer's responsibility is regarding updating approved APS when a new boxed warning has been added to a product's TMA? Does this need to be done proactively, i.e., materials updated prior to expiry? Or can they be updated as each piece expires?
Good morning @karen-taylor
It is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. The addition of a new boxed warning would be considered significant and require the proactive update of all pieces in a timely manner. See also Q&A 337
