583 - A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.



  • You can describe the change in TMA in an accurate fashion. This may include a side-by-side presentation of the prior indication copy compared with the current content. Clarity is of the essence when doing so. All provisions in the code apply but you must be cautious not to accord clinical significance to the change (e.g. by attributing a reason to the change, by presenting possible consequences of the change, etc.)


Log in to reply