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.
337 - When we have an update on our product monograph, do we need to revise the piece related to the product and resubmit to PAAB right away or we can wait for the PAAB renewal date?
Terms of Market Authorization
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Advertising is required to be consistent with the Terms of Market Authorization (TMA) per Food and Drugs Act section 9.1 and PAAB code section 3.1. If the TMA changes such that the advertisment is no longer consistent with it, then the manufacturer must update the advertisment promptly. It is possible for the provided preclearance period to be rendered invalid by factors including TMA updates and market place changes. Please call the PAAB office if you want to discuss your specific situation.
