On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
1/7/2025
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Clinical Trials ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Institutional Review Board (IRB) ,
International Harmonization ,
Investigations ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Office for Human Research Protections (OHRP) ,
Prescription Drugs ,
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