FDA May Clarify When Responsibility Prompts Park Doctrine Prosecutions
This article was originally published in The Rose Sheet
Executive Summary
FDA is considering whether a breach of duty to act or correct violations under the FDCA 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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