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.”
The scientific workshop that led to the formation of the consortium – “Roadmap for Applying Regulatory Science to Neonates” – was held at the FDA on October 28–29, 2014: fda.gov/Drugs/NewsEvents/ucm410863.htm.
INC accelerates the development of safe and effective therapies for neonates. The consortium engages the global neonatal community – families, neonatal nurses, academic scientists, regulators, pharmaceutical investigators, advocacy organizations, and funders – to focus on the needs of the neonate. Through teams that share data, knowledge, and expertise, INC advances medical innovation and regulatory science for this underserved population.
