On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
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New Guidance ,
Pharmaceutical Industry ,
Scientific Research
On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more