329 - Once a patient website for a medication is PAAB approved, do the footnotes and references need to appear in the copy of the live site?



  • Let us know at the initial submission stage whether the reference list will appear within the patient information piece. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece. Either way, note that we require the reference list (and annotated references) for our review of the APS content. Footnotes which are approved as part of the copydeck must appear in the piece. In fact, all APS content must always appear exactly as approved.


Log in to reply