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!