{"Name":"Kathy P. Lee","Level":"Managing Associate","ExceptionLanguage":"","PracticesPreviewOverride":"","ExtensionceAttorneyExperience":"","ExtensionceAttorneyProBono":"","MembershipsAndAffiliations":"","CredentialsOverride":"","AdmissionsOverride":"","MobileExperienceHeader":null,"MobileExperienceNext":null,"PublicationLabel":"Publications","EventLabel":"Events","NewsLabel":"News","NewsletterLabel":"Newsletters","StoryLabel":"Stories","RichTextAreasModule":{"RichTextAreas":[{"Title":"","Overview":"","OverviewExpanded":"

KATHY LEE is a managing associate in the Food, Drug and Medical Device group. Her practice focuses on advising life science companies on a range of compliance, litigation, and enforcement matters involving the Federal Food, Drug, and Cosmetic Act (FDCA), current Good Manufacturing Practices (cGMP), data integrity, and regulatory inspections. She also represents companies in government enforcement actions and investigations in connection with the False Claims Act (FCA) and the Anti-Kickback Statute (AKS).

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Meena Datta, Ben Correa, and Kathy Lee discuss best practices for navigating these 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