We are developing a multi-product lowest level APS regarding a Patient Support Program (PSP) for enrolling patients into the PSP via website (online portal). The APS is generalized, one page document with several product names and instructions to access the website and contact numbers. No therapeutic or Pharmacologic claims are available.
Therefore, could you please clarify whether it is acceptable if the indication statement is not included in this piece. Thank you.
S
Supriya
@Supriya
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.
Posts
-
Clarification on indication inclusion in multi-Product APS -
Cross linking the disclaimer "Clinical Significance has not been established"We are preparing a marketing material with comparative claims and would like to cross reference different market benefit claims to one disclaimer in the piece "Clinical Significance has not been established". I am a bit unclear how this cross referencing can be done. May I seek your help please. Thank you.