On August 29, 2011, the FDA released draft guidance entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.” FDA published the draft guidance to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investigations. The guidance describes a risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study. For example, the guidance encourages greater use of centralized monitoring methods where appropriate. The guidance also makes recommendations about how to develop monitoring plans and document monitoring activities. While interested parties may submit comments on the guidance at any time, the agency is requesting comments by November 28, 2011.