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446 - Can you confirm whether Code sections 2.10.1 and 2.10.2 are mutually exclusive? For example, could an abbreviated indication appear with the first marketing claim in an APS, with the verbatim indication appearing elsewhere in the APS?
Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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2.10.1 and 2.10.2 are not mutually exclusive. A statement conveying all boundaries of patient selection must be presented among (or prior to) the first set of marketing benefit claims in the APS. This statement may be the verbatim indication (thus satisfying both 2.10.1 and 2.10.2), or it may be some other statement identifying all boundaries of patient selection in an alternate format (e.g. “Only use drug X in patients who…”). In the latter case, the verbatim indication must still appear somewhere in the piece. Additionally, use of the statement “indicated for” should be restricted to the verbatim indication. Refer to the PAAB guidance document “Guidance on indication placement in advertising” for additional information.
