When can indications be omitted from an APS
In what scenarios can the indications be left out of an APS?
If the only content is the drug name + branch of medicine (ex. Hematology), can indications (and balance) be omitted?
Jennifer Carroll last edited by
The indication (and at minimum lowest level fair balance) is required for all pieces which have a link to therapeutic use or contain marketing benefit claims about the product both explicit or implicit (Code section 2.10 and 2.4). The “branch of medicine (ex. Hematology)” alludes to a drug’s therapeutic use and would require indication and fair balance. The document Tips_and_checklist_for_creating_and_selecting_fair_balance provides assistance for selection of the level of fair balance. Additionally, PAAB Q&A 303 highlighting the exemption criteria which “branch of medicine” would not qualify for, 317 on inclusion of the indication, and 740 provides another example of a claim that would prompt inclusion of indication and fair balance.