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Legal Issues Policy Compliance

US FDA May Clarify When Execs Can Be Criminally Prosecuted Under Park Doctrine

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Executive Summary

Agency is considering whether a breach of duty to act or correct violations under the Food, Drug and Cosmetic Act must occur before criminal charges are brought, Chief Counsel Rebecca Wood says; clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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