K&L Gates' FDA practice, focusing on food, drug, device, and cosmetic regulatory and compliance matters, is an experienced and integrated team with a proven track record in all areas the FDA regulates. We help clients navigate the regulatory process throughout the life cycle of their products—from planning and development, to approval and marketing, to enforcement and ongoing compliance.
In addition to addressing regulatory issues after companies have funding and patents in hand, we assist with regulatory due diligence and other transactional needs. Our clients include domestic and international manufacturers and distributors of food, dietary supplement, pharmaceutical, biological, medical device, tobacco, personal care, and cosmetic products, as well as trade associations, individuals, and institutions involved in preclinical and clinical research of FDA-regulated products.
We offer clients multidisciplinary, global, regulatory, and transactional advice to help address FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Consumer Product Safety Commission (CPSC), and other agency hurdles. We have excellent working relationships across the government agencies that regulate life science companies.
We Understand the Science Our FDA team not only has significant legal and regulatory experience, but many of us have scientific degrees in areas such as biology, molecular biology, neuroscience, and engineering, as well as first-hand experience with biomedical research. As the scientific landscape continues to evolve, we have the knowledge necessary to assist clients with the regulatory challenges affecting new drugs, monograph drugs, alternative medicines and therapies, medical devices, radiological products, food, nutraceuticals, dietary supplements, medical food, cosmetics and other personal care and “combination” products.
Our Global Platform K&L Gates’ global platform allows our FDA team to offer domestic, international, and multinational companies 24/7 availability and a unique position from which to advise on research, approval, registration, import, export, and recall matters involving FDA-related issues on the East and West coasts of the United States, as well as throughout Canada, the European Union (EU), Japan and the Pacific Rim, Latin America, and other markets.
We provide strategic direction on research and development and market entry pathways for clients seeking to enter the drug and biologics market. We assist with the IND, NDA, ANDA, NADA, ANADA, BLA, and Biosimilar approval and orphan designation processes. The value we provide to our clients does not stop when the FDA issues an approval letter. We also work with our clients to maintain compliance with FDA post-approval requirements, including labeling, advertising, cGMPs, and inspectional issues, and we help clients respond to enforcement issues and numerous other regulatory matters before FDA, Drug Enforcement Agency (DEA), FTC, and state agencies. Our lawyers understand our clients’ businesses and often play a major role in strategic decisions concerning life-cycle management, Hatch-Waxman (paragraph IV) patent challenges or defenses, and related competitive marketing activities.
We also advise on the medical therapies that do not require FDA preapproval, such as products subject to over-the-counter monographs, the DESI program, homeopathic rules, and grandfather statutes. We counsel clients on the risks, limitations, and legal boundaries for marketing claims for such products. Our lawyers also handle regulatory due diligence investigations and review contractual language for joint venture, investment banker, and venture capitalist transactions.
We advise established and emerging companies engaged in developing, manufacturing, and marketing medical devices, in vitro diagnostics, medical equipment, eHealth/mHealth/medical software, combination products, and biotechnology. We counsel on issues throughout the product life cycle, including market entry strategies, premarket submissions (510(k)s, PMAs, IDEs), product development plans, clinical research, labeling and promotional activities, competitor strategy/trade complaints, adverse event reporting, recalls, and enforcement defense.
We provide customized strategic advice for FDA-regulated devices positioned at the cutting edge of science, regulation, and public health policy. This includes conducting compliance audits, drafting regulatory SOPs, advising investors and underwriters, and developing regulatory strategy for clients in most therapeutic areas including clinical chemistry and clinical toxicology, cardiovascular, general hospital, radiology, physical medicine, and neurological devices. Our device practice also includes a strong transactional focus. We conduct FDA regulatory due diligence investigations; assist with the preparation of reports and disclosures to the SEC; draft supplier, manufacturer, and distributor agreements; prepare clinical research agreements; and conduct in-house regulatory and executive training sessions.
Consumers insist upon effective food safety regulation. Businesses seek clarity and predictability. The process is increasingly complicated by the industry’s global scope. Our FDA team has decades of experience, in effectively addressing the issues and problems that arise for growers, manufacturers, associations, cooperatives, technology providers, and other interests in this area. We provide crisis management in recall situations; counsel on ingredient, labeling, and advertising matters; regulatory strategies for conventional food, functional food, dietary supplements, and medical food; compliance with dietary supplement GMPs; representation in enforcement proceedings; and a comprehensive range of other services for the food sector.
Our food practice also helps prepare Generally Recognized As Safe (GRAS) and food contact notifications, GRAS self-affirmations and safety evaluations, and new dietary ingredient notifications for dietary supplements. In the inspection area, we have extensive experience on issues involving the application of cGMPs, HACCP, and other compliance mechanisms to FDA-regulated products.
Our EU regulatory food practice offers strategic legal advice to a broad array of clients in the food and drink industry. We have experience in a wide variety of areas including EU regulatory law and policy (free movement of goods, customs classifications, quotas), food labeling and advertising issues (health and nutrition claims, geographical indications and designations of origin), product registration (novel foods, food supplements, food for special medical purposes, cosmetics, etc.), and product liability (withdrawals, recalls), among others, with particular focus on innovative foods and drinks.
For clients that are seeking to expand their products into the EU, we help to navigate them through all aspects of the EU regulatory process. With more than 1,500 nutritional supplements and functional foods registered in the EU countries during the last eight years, we provide global clients with legal advice, creative solutions, and specific strategies for products being imported or marketed into the EU.
Technology advances often blur the cosmetic/drug/device distinction and have fostered a reevaluation of cosmetic safety and intended purposes. Our lawyers routinely advise companies on the critical definitional distinctions between cosmetics or personal care products and drugs/medical devices. We also assist clients in crafting labeling claims that comply with FDA and FTC requirements, including scientific substantiation and safety. Our lawyers are attuned to company and user concerns and to the innovation that is key to the industry. We counsel manufacturers, retailers, marketers, importers, exporters, and formulators on these and other issues such as “organic” claims, testing and claim support, inspections, import detentions, and product recalls. We also help clients identify and meet related state, federal, and international requirements, such as limits for volatile organic chemicals, labeling under California’s Proposition 65, reporting requirements under California’s Safe Cosmetic Act, and the EU’s REACH requirements.