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
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342 - In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?
Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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The indication statement must be presented verbatim once in the APS per section 2.10 of the PAAB code. The other segments mentioned in your question need not be verbatim but they must reflect the essence of the product monograph. Please refer to the guidance documents on the PAAB website for requirements relating to fair balance format in drug advertising.
