Description of Collaborative Activity: |
Launched on May 19, 2015, INC is C-Path’s ninth consortium – a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. “By uniting stakeholders from research institutions, drug developers, regulatory agencies, patient advocacy and other organizations,” said Janet Woodcock, Director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA/CDER), “INC can develop practical tools that can be incorporated into clinical trials for neonates, which will then lead to more successful, efficient trials and provide this population with better treatments.” |
