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  4. 83 - Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners trademarks.
PAAB Notice
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.

83 - Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners trademarks.

Scheduled Pinned Locked Moved Patient Info
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    The PAAB code allows a maximum period of 12 months for PAAB clearance acceptance of all Advertising/promotion Systems (APS) that do not include market share or price claims. If the APS is to be used longer than 12 months then the sponsor should submit a renewal submission request for pre-clearance review. Information about the drug or marketplace conditions may change over time.

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