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.
10 - What does "well-controlled and/or well-designed" in s. 3.1.1 mean?
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We generally ask for double-blind, randomized trials as reference support for advertising claims. They should be controlled by either placebo or an active comparator, and should be statistically analyzed. In the case of active comparators, it is important to note that the drugs must be compared under the same conditions of use (s. 5.2).
