Regulatory Policy Role In Guiding Decision Making In Cder

Summary

Stefanie Kraus, JD, MPH, Senior Regulatory Council for the Division of Real-world evidence is information on patient's health and health care that comes from multiple sources within and outside the ... This conference on Developing Real-World Data and Evidence to Support Content in this video provided updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and ... "Dr. Carolyn Wilson, Associate Director for Research Center for Biologics Evaluation and Research at the FDA discusses ... Jerry Ellig explains why it's important to consider the end goal of FDA works with academic researchers, pharmaceutical companies, and other healthcare organizations to help identify scientific ... Dr. Marie Bradley, Senior Advisor for Real-World Evidence at FDA's Center for Drug Evaluation and Research, presents an ... The NHC and the Duke-Margolis Center for Health Data standards make the exchange of data predictable, consistent, and in a form that a scientific tool can use. Data standards help ...