How Can US FDA Bolster Drug Development? The Agency Wants Your Advice
Executive Summary
Public meeting scheduled for November to seek recommendations for policies that FDA could implement short-term to promote drug development programs.
You may also be interested in...
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.
Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock
Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.