FDA Releases New Guidelines for Oversight of Clinical Trials

This past week, the Food and Drug Administration released Guidance for Industry on “Oversight of Clinical Investigations – A Risk-Based Approach.”  The purpose of the Guidance is to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical studies of medical devices, human drug and/or biological products. While these guidelines are not mandatory, they do reflect the FDA’s thinking on the topic and are certainly industry-based recommendations. In this new Guidance, the FDA describes strategies that reflect a modern, risk-based approach…
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