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FDA-Regulated Products
Overview
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. Companies, patient organizations, and other stakeholders rely on us to provide experienced advice to help them meet regulatory expectations and navigate the FDA when they’re working with new drugs, biologics, and medical devices and related biotechnology or innovative food products and cosmetics.
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 the life cycle of a medical product — from the early research stages to the clinic, to Agency submission and approval, and on to post-marketing commitments and ongoing safety monitoring.
Our experienced team members have worked on issues before the FDA’s Center for Drug Evaluation and Research including drug and biologics policy matters before the Office of Pharmaceutical Quality and compliance matters (including 483 responses and warning letters) before the Office of Compliance. The team leverages an interdisciplinary bench of attorneys, consultants, and scientists to provide you with insight and practical advice. We handle matters including:
- Clinical trial contracting
- Research compliance
- Product development strategy and early agency interactions
- Patient-focused drug development (including patient advocacy group collaborations)
- Software as a medical device
- Current good manufacturing practice (CGMP) and quality system regulations and expectations
- Laboratory audits
- Agency determinations (i.e., INDs, IDEs, and expanded access)
- Risk evaluations and mitigation strategies (REMS)
- Promotional communications and advertising
- Privacy protection policies and enforcement
- Post-marketing surveillance
We also support clients as they innovate using advanced manufacturing techniques and platform technologies, 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, product recalls, or legal suits emerge, our regulatory and litigation teams provide peace of mind as you implement new compliance protocols or tackle high-stakes litigation.
Cosmetics
Makers of cosmetics and personal care products must continuously adapt and expand product offerings to reflect the growing desire of consumers to express their beauty and individuality. At the same time, oversight has never been greater, as we watch FDA implement federal legislation to modernize cosmetics regulation. Creative marketing and advertising of these products may fall outside legal parameters 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, help navigate registration requirements, and advise on prospective advertising and labeling claims that are the basis for legal challenges by regulators and competitors.
Animal Health
Companies making new animal drugs, medicated feeds, and feed additives, as well as pet food and animal feed, need in-depth knowledge to identify applicable regulations and implement efficient development, manufacturing, and marketing of animal food and drugs. We guide clients through interactions with the FDA and the US 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.
