Thank you @Jennifer-Carroll!
S
Supriya
@Supriya
Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Posts
-
Clarification on Product Available now! message in the APS -
Clarification on indication inclusion in multi-Product APSThank you @Jennifer-Carroll. This is very helpful!
-
Clarification on Product Available now! message in the APSHi, I would like to confirm whether a sell-sheet containing new product availability information is subject to PAAB review if it includes the name of a third-party program for ordering the product.
Thanks
-
Clarification on indication inclusion in multi-Product APSThank you Jennifer. The website is exclusively intended for healthcare professional and is not designed for patient use. Therefore, we seek clarification on whether the inclusion of an indication statement may be deemed unnecessary, given that the material does not contain any therapeutic or pharmacologic claims.
-
Clarification on indication inclusion in multi-Product APSWe 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. -
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.