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