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FDA Issues Final Guidance on Informed Consent in Clinical Investigations | McDermott Will & Emery

Published: September 6, 2023

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document...

Source: jdsupra.com

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Human ServicesDrug AdministrationUs Department Of HealthMcdermott WillInformed ConsentClinical InvestigatorsInformed Consent Information SheetInstitutional Review BoardsFederal PolicyHuman SubjectsElectronic Informed ConsentClinical Investigations