IRB review of FDA-regulated research requires the interpretation and application of regulatory standards that are different from, and often in addition to, those of the Common Rule. Effective review requires the ability to identify studies that are FDA-regulated, an understanding of how diverse products become test articles, and knowledge of investigational new drug (IND)/investigational device exemption (IDE) requirements. This workshop will provide participants with a stepwise process and framework to identify and apply these unique regulatory requirements to IRB review and the oversight of FDA-regulated research. This session will take place in Zoom meeting. The use of attendee video is encouraged for participation and interaction with your peers.
Examine when an activity falls under FDA regulations
Outline a step by step framework for applying FDA regulations in clinical investigations