The NCCN guidelines for a cancerX recommended products of class A for Stages III-IV in line with the recommended label. However, they have just been updated to include same products for Stages II-IV, recognizing that "supporting data are limited for stage II". The rationale for this revision / inclusion is the following: "Cases of stage II disease at initial diagnosis are rare, especially among patients who have undergone complete surgical staging, so there are little data and low probability of future trials that will address the question of whether it is appropriate to use class A as maintenance after completing primary therapy for stage II disease." Our question to the PAAB is whether we can use these new recommendations as part of the promotional materials with a disclaimer that our indication is for "advanced stages of cancerX".
F
Fernand
@Fernand
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
-
consensus guidelines -
Use of Brand Name for combination productThank you for your response. Would this still apply if Product B did not have the indication? or if the indication is expected soon?
-
Use of Brand Name for combination product"Product A just received approval for new indication to be used in combination with Product B. The indication reads :
Product A (brand name) in combination with product B (generic name) is indicated for first-line treatment of....
When using Product A (brand name) in combination with product B (generic name), consult product monograph for Product B (Brand name) for further information on this drug.
Q: would we be able to use Product B's brand name and logo in the APS?"