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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625 - For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?
Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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The document “Tips and checklist for creating and selecting fair balance” on the PAAB website provides a list of questions that can help you determine what level of fair balance is required based on the messaging within the piece. A presentation where the highest level of messaging is restricted to dosing and administration information such as “dosage form” and “dosing instructions” would fall under the category of “Non-pharmacologic claims” Lowest level fair balance is sufficient to balance non-pharmacologic type claims.
