federal_register: 2023-07687

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2023-07687 A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "A Risk- Based Approach to Monitoring of Clinical Investigations--Questions and Answers." This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled "Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring" (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled "A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers," issued on March 15, 2019. 2023-04-12 2023 4 https://www.federalregister.gov/documents/2023/04/12/2023-07687/a-risk-based-approach-to-monitoring-of-clinical-investigations-questions-and-answers-guidance-for https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07687.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "A Risk- Based Approach to Monitoring of Clinical Investigations--Questions and Answers." This guidance provides information on...  

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