US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’

 
• By Derrick Gingery

Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.

Gantt chart
OCE officials sponsors to plan for the confirmatory trial to be ongoing at the time of an accelerated approval. • Source: Shutterstock

Sponsors should expect increased pressure through the review pathway to ensure products receiving accelerated approval confirm benefits as stakeholders continue working to strengthen the system.

Oncology Center of Excellence Director Richard Pazdur wants to squeeze the US Food and Drug Administration’s so-called “period of vulnerability”...

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