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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 134 - I'm puzzled by an ad on the cover of a specialist journal, announcing that a product is now availabile in Canada. There are no other claims or description of the product, other than suggesting the physician call the pharma company for more information or samples. I'm puzzled becuase the ad has no balance copy, no warnings, and has not been PAABed; there is no prescribing information. The company must feel that the ad falls out of the scope of the PAAB Code, but i don't see any of the exemptions applying. Plus, launch is a time when MDs are particularly in need of info regarding safety information. The masthead says that all drug ads have been cleared by PAAB, but this is clearly not the case. Is there something I am missing?
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.

134 - I'm puzzled by an ad on the cover of a specialist journal, announcing that a product is now availabile in Canada. There are no other claims or description of the product, other than suggesting the physician call the pharma company for more information or samples. I'm puzzled becuase the ad has no balance copy, no warnings, and has not been PAABed; there is no prescribing information. The company must feel that the ad falls out of the scope of the PAAB Code, but i don't see any of the exemptions applying. Plus, launch is a time when MDs are particularly in need of info regarding safety information. The masthead says that all drug ads have been cleared by PAAB, but this is clearly not the case. Is there something I am missing?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Advertising conveying no claims other than the commercial message that the product is now available is exempt from PAAB review under PAAB code s1.5 (use of drug name only in a context not linked to a therapeutic message in any way). Please call me at the PAAB office if you have any questions about this answer.

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