Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
Does Part 3's 'indication' require safety information?
-
Hi there!
I know in the Branded Patient Information Guidelines (https://code.paab.ca/resources/Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf) in section 1.4, it is mentioned that if "the APS includes information on how the drug works and its various features from part III", safety information is required. I was wondering if the Part III version of the indication (I think it's usually subheaded with "What is DRUG used for?" or similar) falls into this category? If a branded patient piece only includes what the drug is used for, would that be considered a "various feature" of the drug and require safety information? Thanks for your help!
-
Hello @kshulist
When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.
