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  3. Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
  4. 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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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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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Whether high, middle, or low level of fair balance (FB) is required will depend on the type of product content conveyed (i.e. whether explicit or implicit [e.g. visuals]). Please refer to the PAAB document “Guidance on Base Fair Balance Level and Selection (HCP Advertising)” available on our website for considerations in this assessment. In cases where FB is required, the indication must also be included in the APS (s2.10). An example where FB and indication would not be required is an ad containing drug name only plus dosage form (NOT dosing instructions) which is exempt from PAAB review (s6.6iv). Regarding the comment about using the sign only at conferences along with brochures containing the indication and fair balance, please note the display sign and brochures would be reviewed as distinct APS and each APS must satisfy the PAAB Code requirements for indication and FB. Similarly, any content related to the booth should also conform to the regulations for product branded advertising.

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