Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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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.
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420 - What are the requirements for display signs at a conference? The display sign contains pictures of drug products and contains general information about the product. Would fair balance need to be applied to this display? Are we required to include the indications on the display? This sign would only be used at conferences along with brochures which contain the indications and fair balance information.
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345 - In light of the new Fair Balance requirements (high level), are we required to include all the laboratory monitoring as part of the warnings and precautions section? It seems like a lot of info given that they are monitoring guidance but not warnings per se (e.g. monitor leucocytes very 4 weeks ...). Please advise.
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344 - Hi Patrick, Lately PAAB has been requesting that the indication for a product be placed on the front page of every piece. If we are not making any clinical claims on a front page of a piece, why can we not include the indication on the second page of a piece? Your PAAB code clearly says: 2.10.2 - PAAB code, The TMA content, "Drug X is indicated for" (or equivalent) must be presented verbatim at least once within the advertising message of the APS. Nowhere does it say it has to be on the front page.....thanks!
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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?
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272 - We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?
