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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 209 - I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!
PAAB Notice
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.

209 - I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Yes, the video should be reviewed by PAAB as it exists due to the sponsor's funding (i.e. not independent created) and it will focus on the sponsor's product. See PAAB code s1.5). Assuming that this is a prescription product, note that the content on the website should be gated (i.e. the general public should not have access to the content as it will invariably exceed the name, price, and quantity restriction). The PAAB will review the patient content under PAAB section code 6. PAAB will also be reviewing the contexts in which you are linking to the video in other APS.

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