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After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft...
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...
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the...