A Risk-Based Approach To Monitoring of Clinical Investigations: Questions and Answers; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "A Risk- Based Approach to Monitoring of Clinical Investigations: Questions and Answers." The draft guidance provides information to sponsors on risk- based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance expands on the guidance for industry entitled "Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring" (August 2013) (the RBM Guidance) by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring.