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.
326 - Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.
-
Comparisons of product properties are permissible as per Code section 5.10.2iii. The comparison should be complete, with no information relevant to the comparison omitted (e.g. the indications must each be complete). The comparison must not appear in the context of messaging implying clinical significance. A disclaimer is required as outlined in the above noted Code section. With regards to the dates, keep in mind that there should be no direct or indirect reference to the approval process ad per c.01.007 of the Food and Drugs regulations.