Platform Trials Could Be A Solution To Expanded Access, Woodcock Says
US FDA will continue expanded access activities as government shutdown continues, but CDER Director Woodcock says that platform trials can help eliminate the need for expanded access to exist.
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Pharma Industry Broadens Its Approach To Expanded Access
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.
Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake
CDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them.
“One Continuous Trial” In Oncology: US FDA Offers Guidance And Encouragement
One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.