17. April 2023: Monitoring of Clinical Investigations: A Risk-Based Approach
![Monitoring of Clinical Investigations: A Risk-Based Approach](https://gouya-insights.com/wp-content/uploads/2023/04/Capture-decran-2023-04-17-a-07.25.41.png)
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 […]