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.
485 - If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?
-
Safety information in advertising must reflect the current product label so as not to contravene section 9.1 of the Food and Drugs Act. There is no formal “grace period” per se. It would behoove manufacturers to take action in a manner which demonstrates prompt re-alignment of advertising to the TMA. Patient safety is paramount.
