When can indications be omitted from an APS
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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? -
Hello @mimic909
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.
