Daily Rules, Proposed Rules, and Notices of the Federal Government
The goal of this course is to engage and educate FDA reviewers, NIH scientists, clinicians, academics and industry representatives with experience in human subject research, seeking to build upon their existing knowledge and to obtain a broader
If you need sign language interpretation during this course, please contact Francesca Joseph at
The FDA-NIH Science of Small Clinical Trials Course is presented by FDA's Office of Orphan Product Development, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health; the NIH Office of Rare Disease Research, National Center for Advancing Translational Sciences; and will also include participation from outside experts in the field. This educational event will consist of live presentations provided by FDA experts from various Centers and Offices, as well as from outside experts. It will also include case studies of regulatory trials and interactive panel discussions. The course will be recorded for subsequent posting on FDA's Web site.
(FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the