422 - Dear PAAB. The PAAB codes states that superlatives or special status cannot be used unless substantiation can be provided. What is the substantiation you are looking for? Is the monograph a source that would suffice?
Jennifer Carroll last edited by
PAAB code section 5.16 requires that claims of status be supported by authoritative sources. The terms of market authorization (e.g. product monograph) for the product in question would indeed be an acceptable source of support. As a courtesy, an alternative source of support could be authoritative consensus guidelines (provided the claim is consistent with the TMA). Note that the claim should be limited specifically to the meaning of the message in that reference. Also keep in mind that context is important to overall meaning.