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.
Advisory on Exclusivity Claims for Indications
-
Expanding the approach to exclusivity claims
@Agency and @Manufacturer A new advisory has been posted on Exclusivity Claims for Indications. If you have any questions, please post below:
-
Expanding the approach to exclusivity claims
@Agency and @Manufacturer A new advisory has been posted on Exclusivity Claims for Indications. If you have any questions, please post below:
-
@admin Thank you for this advisory.
-
Does the font for the indication of product B need to be the same size as the font of product A?
-
If an APS mentions product A by brand name, is it acceptable to refer to product B by its generic name?
Hello @natbourre
- No, but the indication size should be proportional to the claim size
- Yes, it is acceptable to use the generic name.
-
-
@Jennifer-Carroll For the exclusivity claim, what level of FB would be required?
-
@Jennifer-Carroll For the exclusivity claim, what level of FB would be required?
Hey @boram
The level of fair balance will be dependent on the exclusivity claim and any additional copy required to support it. For the exclusivity claims discussed in the above document, highest level fair balance would likely be required as these are indication comparisons. See Question 1 in Guidance on Fair Balance Level Selection and Placement