US FDA Advisory Committee Open Public Hearing Changes Urged

 
• By Sue Sutter
  
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Patients want more attention paid to their experiences with an investigational drug, while consumer groups and academics say those who were harmed also should be heard.

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Stakeholders disagree about the shortfalls in the existing open public hearing process. • Source: Shutterstock

Patient groups want more attention paid to their experience during the open public hearing portion of US Food and Drug Administration advisory committee meetings, while consumer groups and academics say the comments are not sufficiently diverse.

Key Takeaways

  • Patient groups say more time and attention should be paid to the experience of patients, clinical trial participants and investigators during the open public hearing of advisory committees.

At a recent listening session on advisory committee reforms, the FDA also heard calls for guidance on how adcomm members...

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