Companies of all sizes engage Shook, Hardy & Bacon for strategic advice related to products regulated by the Food and Drug Administration (FDA)—including food and beverages, prescription and non-prescription drugs, cosmetics, medical devices, and animal feeds and drugs. Coupled with our first-hand knowledge of our clients’ businesses, our vast network of relationships with FDA-regulated companies as well as supporting organizations and associations enables us to offer innovative strategies and focused practical advice related to complex product development, operations, commercialization and post-market challenges.
Knowledgeable about every stage of the product lifecycle, our attorneys provide guidance on research agreements; clinical trial compliance, enforcement and litigation issues; FDA review strategies; pre-approval activities; good manufacturing practice requirements; safety, pharmacovigilance and REMS; FDA promotion rules; Office of Prescription Drug Promotion (OPDP) enforcement; and Food, Drug, and Cosmetic Act (FDCA) and health care law compliance. We also help clients navigate complex food and beverage regulations such as the Nutrition Labeling and Education Act (NLEA), FDA Reportable Food Registry and Food Safety and Modernization Act, as well as the processes for evaluating generally recognized as safe (GRAS) ingredients and product health claims. We offer legal support on a range of product operations and commercialization issues stemming from product launches, specialized contracts, supplier agreements, supply chain safety, insurance coverage and compliance audits, and litigation.