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Home » US FDA warning letter spells out expanded access duties
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US FDA warning letter spells out expanded access duties

June 21, 2024
By Mari Serebrov
Communication missteps, overreliance on a contract research organization and lack of clarity of U.S. FDA expectations for an expanded access protocol for emergency use resulted in a warning letter posted June 18 that highlights potential pitfalls for sponsor/investigators conducting the individualized studies.
BioWorld Regulatory U.S. FDA

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