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Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations

On September 28, 2022, the U.S. Food and Drug Administration issued two Notices of Proposed Rule Making to harmonize FDA’s regulations pertaining to human subjects research and the review of cooperative research by a single institutional review board with those of the Federal Policy for the Protection of Human Subjects. Earlier in September, FDA also issued a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

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Fourth Circuit Holds False Claims Act Relators to Strict Pleading Standard: Ruling Will Be Particularly Useful in Defending Off-Label Promotion Cases

Practices: Health Care, False Claims Act, Government Enforcement / White Collar Criminal Defense

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