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.
How does PAAB define the start of marketing for "new" claims?
-
Hi there!
I know that messages of "new" (or "introducing") are limited to one year post-marketing. I am wondering how PAAB defines the date that is considered the start of "marketing"?
For example, Drug X gets NOC on Oct. 13, 2023, however, the first official marketing piece is only released to HCPs (e.g., a "Now Available" email) on Mar. 4, 2024. Does that mean that "new" can be used until Mar. 4, 2025 (since the marketing didn't officially start until Mar. 4 2024)? Or would "new" only be allowed to be used until Oct. 13, 2024 (as per the NOC date)?
If it is based on the date the first marketing material is released (e.g., Mar. 4, 2024), does PAAB required some kind of confirmation letter from the company supporting that specific date as the start of marketing? (e.g., perhaps if a material was submitted after Oct. 13, 2024 but still included a "new" message)
Thank you so much for your help!
-
Hi there!
I know that messages of "new" (or "introducing") are limited to one year post-marketing. I am wondering how PAAB defines the date that is considered the start of "marketing"?
For example, Drug X gets NOC on Oct. 13, 2023, however, the first official marketing piece is only released to HCPs (e.g., a "Now Available" email) on Mar. 4, 2024. Does that mean that "new" can be used until Mar. 4, 2025 (since the marketing didn't officially start until Mar. 4 2024)? Or would "new" only be allowed to be used until Oct. 13, 2024 (as per the NOC date)?
If it is based on the date the first marketing material is released (e.g., Mar. 4, 2024), does PAAB required some kind of confirmation letter from the company supporting that specific date as the start of marketing? (e.g., perhaps if a material was submitted after Oct. 13, 2024 but still included a "new" message)
Thank you so much for your help!
Hey @kshulist
In general, PAAB may request a confirmation letter from the company when there is a large discrepancy between the NOC and the submission of the “new” claim or when previous pieces with the copy “new” have been approved for a period of time that is getting close to or is past one year. When in doubt, it never hurts to proactively include a letter from the sponsor outlining the first date marketing activities were released (e.g. Mar 4, 2024) and confirmation that pieces containing “new” will be pulled from the market 1 year post the first piece entering the market.
-
Hey @kshulist
In general, PAAB may request a confirmation letter from the company when there is a large discrepancy between the NOC and the submission of the “new” claim or when previous pieces with the copy “new” have been approved for a period of time that is getting close to or is past one year. When in doubt, it never hurts to proactively include a letter from the sponsor outlining the first date marketing activities were released (e.g. Mar 4, 2024) and confirmation that pieces containing “new” will be pulled from the market 1 year post the first piece entering the market.
@jennifer-carroll Thank you Jennifer!
