Hello @dmauri
PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.
Good Morning @Jennifer_CM
Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).
Thank you @Jennifer-Carroll!
Hey @Supriya
This appears to be a specific question about a specific piece. Copy around “new product availability” is broadly open to interpretation. PAAB would also need to see the third-party program site to assess the combination of all messaging within the piece and the linked content. We suggest submitting for an opinion.
Jennifer, thank you very much for your prompt answer. We will do that.
Thank you @Jennifer-Carroll. This is very helpful!
