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.
740 - Dear PAAB, The Product Monograph of one of our products has been updated with a new indication. We want to send a message to physicians informing them that the PM for AAA product has been updated with the results of BB study. Since there is no claim/indication in this message, our understanding is that this message is PAAB-exempt. Can you please confirm? Thank you.
-
A message of “new indication” would be promotional (promotes the feature of a product) and incomplete (what is the new indication). This is not considered an exempt message. Please see PAAB section 1.5 for exempt messages. A message similar to “new data within the TMA” is also a promotional claim and does not fall under the exemption criteria.