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FDA (Finally!) Issues Proposed Rule to Amend FDA Regulations on the Protection of Human Subjects and Institutional Review Boards | King & Spalding

The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and...
Drug Administration Health Information Agency Investigational Device Exemption Institutional Review Boards Federal Policy Human Subjects

Department of Health and Human Services Office for Human Research Protections Publishes New Guidance for Reporting Incidents | Butler Snow LLP

On November 9, 2022 the Department of Health and Human Services Office for Human Research Protections (OHRP) published a new Guidance clarifying the requirements for reporting incidents...
Butler Snow Human Services Office For Research Protections Department Of Health Human Services Office Human Research Protections Federalwide Assurance

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Seeking harmony: FDA to align its human subject research regulations with Common Rule Some divergence between the regulations would remain intact | Hogan Lovells

Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal...
United States Hogan Lovells Clinical Trials Transformation Initiative National Institutes Of Health Department Or Agency Federal Food

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