How does PAAB define the start of marketing for "new" claims?
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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!
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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.
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@jennifer-carroll Thank you Jennifer!
