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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?

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

  • Correct any misunderstandings
  • Provide guidance when questions remain unanswered after a few days
  • Support discussions where official clarification is needed

Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.

Thank you for being part of the conversation.

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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