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.
173 - Do personal (i.e. one to one, not mass generated) emails to HCPs announcing a product is "now available" need PAAB pre-clearance review? May such emails that mention a product also include brief mention of the general indication, disease state or therapeutic use? Thanks!
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No, PAAB preclearance is not required for any piece containing only the drug name and the claim "now available". This is true whether the same piece is sent to one HCP or many HCPs. However, adding anything else (e.g. the indication, disease state or therapeutic use) renders it PAABable. Additional related notes: Situations where the piece is provided to an individual in response to a request for information that has not been solicited in any way is exempt from pre-clearance. It appears unlikely that an HCP requests a piece containing the message "Now available" and the product indication. Note that simply personalizing the greeting line (i.e. Dear Doctor John Doe) does not render the piece exempt for PAAB preclearance when the intent is to send the core message to multiple HCPs.
