654 - Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.
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When setting out to link branded and unbranded content, all content becomes branded. It is possible to link to third party independently created website from a standard setting organization (i.e. reputable patient associations). We suggest that the link be made to the homepage, in which case the PAAB would assess the link as part of our review of the Patient Support Program submission to ensure that the linkage is not off-label. However, if the manufacturer were to link the submission to specific sections of the independent site (instead of the simply linking to the home page), the PAAB would need to perform a complete review of those sections as one or more separate submissions. Those reviews would be performed under a product branded lens.