Can a company create a disease awareness pieces on a therapeutic area they do not have any product approved yet (Pre-NOC)? For example, if the company creates a website or an article for a magazine/ journal that does not allude to any product, can this have the logo of the company? Is there a difference if the audience is General public vs HCPs? Is it Ok for a pharmaceutical company to include information about the disease in the social media platforms of the company?
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@Sil
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Posts
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Disease awareness Pre-NOC -
Superiority ClaimHello, Is it possible to do an ad based on a peer review randomized Head to Head clinical trial that compares our Drug A with Drug B (both approved by HC for this indication). This clinical trial demonstrated superiority of Drug A vs Drug B. Our PM does not provide information about superiority against this drug (pivotal studies did not compare against this drug), however, we have comparison using the same endpoint against placebo. Is it possible to claim superiority in this case?
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Submission requirement for translationHi. The company medical/regulatory staff needs to review the material prior to submission to PAAB. When the material was already approved in English (internally and by PAAB), is it mandatory for medical/regulatory staff to review the translation too? The translations are done and reviewed by certified translators.
Thank you