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Confirmatory Trials: US FDA Expectations Become Clearer Amid FDORA Flexibilities

 
• By Sue Sutter

Two recent accelerated approval guidances describe the FDA’s policy expectations for trial timeliness, but recognize the need for case-specific determinations. Regulatory actions in 2024 show the FDA is willing to delay application filing or approval over confirmatory trial status.

2024/2025 Pink Sheet Perspectives
New FDA guidance offers more clarity about the timing of confirmatory trials. (Shutterstock)

The US Food and Drug Administration’s expectations for the timing of accelerated approval confirmatory trials came into clearer focus in 2024 with new policy documents and real-world examples.

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