This month, FDA officially released the new Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.  The draft guidance was originally released in August 2011, and has been a popular topic of conversation over the two year period before becoming final.  You may recall a recent blog we posted about the concept of Risk-Based Monitoring and how it seems to be met with some skepticism and confusion amongst the clinical research community.  Hopefully now, with FDA’s “current thinking” on the topic becoming official, we can all review what exactly FDA’s vision for the future of monitoring entails.