17. April 2023: Monitoring of Clinical Investigations: A Risk-Based Approach

Monitoring of Clinical Investigations: A Risk-Based Approach

Wien, 17.04.2023 – Text: Catarina Carrão The U.S. Food and Drug Administration (FDA) has just released an extension to the guidance “A Risk-Based Approach to Monitoring of Clinical Investigations”, previously published in 2013. The new guidelines are intended for clinical investigations regarding human drug and biological products, medical devices, and combination products; and it offers recommendations […]