We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.
ContinueLearn More XWhite Paper
August 30, 2012
Does publication of its Draft Industry Guidance, Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring, signal a shift in FDA’s philosophy of the monitoring of clinical studies for device approvals? In the guidance document, FDA states it wants to make clear that “sponsors can use a variety of approaches to fulfill their responsibilities” and will encourage strategies that “reflect a modern, risk-based approach specifically encouraging greater use of centralized monitoring methods where appropriate.”
Download to find out more.