SIUU (Scientific Information on Unapproved Uses) and unsolicited off-label requests are distinct pathways for communicating medical information. SIUU involves proactive, firm-initiated communications about unapproved uses and does not apply to responses generated by healthcare professional (HCP) inquiries. These communications must be supported by credible published sources such as peer-reviewed journals, clinical practice guidelines, reference texts, or digital clinical resources, with updated guidance allowing firm-generated summaries of such evidence. In contrast, unsolicited off-label requests originate from HCPs and can occur in private or public settings. Responses are reactive rather than proactive and are not limited to specific source categories, but must remain truthful, accurate

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