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FDA Issues Draft Guidance on "External Controls" in Clinical Trials to Support Safety and Efficacy of a Drug | King & Spalding

Published: March 8, 2023

The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the...

Source: jdsupra.com

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World Evidence ProgramDrug AdministrationExternally Controlled TrialsBiological ProductsControls DraftCentury Cures ActCures ActWorld EvidenceExternal Controls Draft GuidanceFederal FoodCosmetic Act