Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says

 
• By Sue Sutter

Accelerated approval sponsors who want to demonstrate due diligence in conducting confirmatory trials should bring a comprehensive program for verifying benefit to the agency early and be proactive in communicating about challenges that could lead to delays, FDA’s oncology review staff say at an adcomm on delayed trials for Acrotech’s lymphoma drugs.  

Hockey net
A comprehensive development plan may provide an opportunity for multiple shots on goal when it comes to confirming an accelerated approval drug's clinical benefit. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers