303 - According to the PAAB Guidance on Base Fair Balance Level Selection and Placement, the indication statement is not a 'claim' that requires fair balance. Therefore if an APS contained only the Drug name (including active ingredient and dosage form) and the indication statment, and no other explicit or implicit claims, would this APS require any fair balance? Would it be exempt from preclearance?

  • The indication is indeed a claim. But it is sufficiently "balanced" with lowest level fair balance general statement (i.e. complete indication with the statement to consult the PM for contraindications, warnings...). The piece you've described is not exempt. Per the document cited in your question, product advertising is only exempt there are absolutely no messages other than drug name +/- claims explicitly listed in the PAAB code s1.5.