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
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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.
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Consumer groups and academics want more transparency into OPH speakers’ conflicts and financial interests
At a recent listening session on advisory committee reforms, the FDA also heard calls for guidance on how adcomm members should weigh OPH testimony in their deliberations, and to release background briefing documents more than two
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