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.
251 - The Code (in part) states: 1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph. 2. patient materials must be non-promotional. The questions, • if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc). • if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.
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Distribution of part III of the PM would not require PAAB preclearance.
Modification (e.g. removal of content, insertion of text/visuals) made to the document for distribution to patients through HCPs would require PAAB even if the resulting document meets the PAAB code 6 requirements for consistency with part III & non-promotional content/tone. Indeed, PAAB pre-clearance is intended to ensure that these requirements are met. Call me at the PAAB office if you'd like to discuss your specific case.
