FDA outlines risk-based approach to monitoring clinical trials (Catapult's regulatory round-up - April)
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19 février 2024
- doi: 10.58079/vv53
info:eu-repo/semantics/openAccess
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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.