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Tag: 21 CFR 56.109[g]

> 21 CFR 56.109[g]
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FDA proposes new rules to harmonize with Common Rule (Part II: protection of human subjects and IRBs) by Elisa A. Hurley, PRIM&R executive director

(PRIM&R) Public Responsibility in Medicine and Research

On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.