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  3. Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
  4. 580 - Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?
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580 - Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?

Scheduled Pinned Locked Moved Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    You may choose to include incidences. Make sure the manner in which they are included is complete, clear, and reflective of the TMA.

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