The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
459 - I'm working in a branded patient-information brochure that includes disease information and dosing. All the content is consistent with part III of the TMA. Does this piece require fair balancing copy? If so, what information is required in the fair balance for patient pieces?
-
With regards to when risk information is required in a patient information piece, refer to page 3 of the following document: http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
With regards which information is required as general risk disclosure, any content emphasized in part III of the TMA (e.g. appearing boxed or bolded) and any content and an HCP (e.g. physician or pharmacist) would be particularly compelled to warn a patient about. It is a best practice to include part III of the TMA (or a link to it) with the piece.
