Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

 
• By Sue Sutter

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’  

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FDA wants cancer drug sponsors to think of studies supporting accelerated approval and confirmatory trials as a single package. • Source: Alamy

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