Like the agency itself, we have dedicated, interdisciplinary practices focusing on each segment of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA). We partner with stakeholders in the food, pharmaceutical, health and life sciences, and other affected industries to navigate FDA regulations and agency interactions. From new medical devices and biotechnology to innovative food products and cosmetics, companies, patient organizations and other stakeholders rely on us to provide experienced advice to navigate the FDA.
Drugs and Medical Devices
As a drug and medical device innovator, patient organization, or other stakeholder in the drug or device approval process, your success relies on your ability to comply with a complex framework of regulations related to research and development, marketing authorization and post-marketing compliance. We support you throughout this process, walking with you from the early research stages, to the clinic, to Agency submission and approval and on to post-market safety monitoring. Our experienced team leverages an interdisciplinary bench of lawyers, consultants and scientists to provide you with insight and practical advice. We handle matters including clinical trial contracting, research compliance, product development strategy and agency relations, patient focused drug development (including patient advocacy group collaborations), good manufacturing practices, laboratory audits, Agency determinations (i.e., INDs, IDEs, and expanded access), advertising, promotion, privacy enforcement and related matters. We also support clients as they innovate using cutting-edge digital, Artificial Intelligence (AI), machine-learning (ML), and other software-based technologies.
Food and Dietary Supplements
Leading food and dietary supplement companies confront critical legal, regulatory and business challenges every day. We help you develop and execute strategies related to the science, economics, markets, government regulation and public relations aspects of the farm to-table cycle. When disputes, regulatory changes or product recalls emerge, our regulatory and litigation teams provide peace of mind as you implement new compliance protocols or tackle high-stakes litigation.
Makers of cosmetics and personal care products must continuously adapt and expand product offers to reflect the growing desire of consumers to express their beauty and individuality. Creative marketing and advertising of these products may exceed lawful conduct and result in enforcement action by regulatory agencies. States have become increasingly involved in cosmetic regulation as it relates to product ingredients and consumer health. We work with you to meet these emerging challenges head-on. We review product ingredients and advise on prospective advertising and labeling claims that are the basis for legal challenges by regulators and competitors.
Companies making new animal drugs, biologics, pet food, feed additives and animal feed need in-depth knowledge to identify and implement efficient development, manufacturing and marketing of animal food and drugs. We guide clients through interactions with the FDA and the United States Department of Agriculture by delivering industry insight and practical advice on complex legal issues related to adverse event reporting, recalls, criminal investigations and product liability.