Docket Number:
FDA-2019-D-0362
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The draft guidance provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and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.

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All written comments should be identified with this document's docket number: FDA-2019-D-0362.