Comparison of FDA Regulations (Current and Proposed) & Common Rule

This document provides a detailed side-by-side comparison of the regulations under Common Rule and current (and proposed) U.S. Food and Drug Administration (FDA) regulations (21 CFR 50/56 etc.), showing how FDA’s human-subjects-research and IRB requirements could be harmonized — or where they diverge — under the proposals stemming from the 21st Century Cures Act.

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