Christine Lentz focuses her practice on FDA regulatory compliance, counselling clients that develop and commercialize FDA-regulated products, including drugs, biologics, medical devices, food and beverage, cosmetics, and dietary supplements. She also has experience navigating complex regulatory requirements that apply to products and services that are regulated by FTC, DEA, CMS, USDA, TTB, CPSC, and state licensing authorities.
Christine supports companies in managing multi-faceted regulatory issues across the product life cycle, from development to product launch and post market compliance, to defending government enforcement actions. In particular, she advises clients on state and federal licensing and registration, labelling requirements, advertising and promotion, as well as commercial agreements. Christine also leverages her regulatory expertise as a subject matter specialist on transactions, conducting due diligence on behalf of clients.
In addition, Christine has experience advising life sciences, digital health, and medical device clients on a variety of health privacy, compliance, transactional, and litigation issues, including compliance with HIPAA and other laws that govern the collection, use, and disclosure of health information. She has conducted multijurisdictional surveys on the regulatory status of telehealth, corporate practice of dentistry, medical device manufacturing, and distribution, as well as analyses of laws and regulations surrounding healthcare fraud and abuse, anti-kickback, False Claims Act, contracting, Medicare and Medicaid reimbursement, state-law laboratory billing, and corporate practice of medicine.