Hello, I work at an agency and one of our clients is considering a website for patients enrolled in their PSP. This website would be DIN gated at which point the patient can create an account using their email address. The patient would then receive a confirm profile email with a link to create a password. Once the account is confirmed, the patient accesses this site with the email address and password. All information within the site falls into the following categories: - navigational content - unbranded therapeutic area information previously approved by PAAB or ASC - branded patient-facing information previously approved by PAAB Our client is deciding if this is something worth pursuing and part of this decision depends on the regulatory requirements. Could you tell me if a website of this nature would require PAAB preclearance and, if so, which parts of the site would be subject to review. Thank you for your input.
When we link branded and unbranded content, all content is considered branded. Linkages include, but are not limited to, temporal, visual, direct or implied. By virtue of the fact that they are registering to the PSP as a patient on a product, all content provided through the patient support program is subject to the PAAB code and review.