FDA outlines risk-based approach to monitoring clinical trials (Catapult’s regulatory round-up – April)
The Food and Drug Administration (FDA) has issued a final guidance to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations involving drugs, biologics and medical devices. This guidance provides recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.
Published on the 2nd of May 2023 in Catapult’s April regulatory round-up.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (19 février 2024). FDA outlines risk-based approach to monitoring clinical trials (Catapult’s regulatory round-up – April). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/vv53





