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FDA Finalizes Guidance on Informed Consent for Clinical Investigations

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”).

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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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