FDA

Companies subject to FDA regulations know how critical compliance can be to the bottom line. Goodwin’s experienced FDA practice provides counsel, representation and strategic advice to companies subject to the Federal Food, Drug, and Cosmetic Act. Our practice covers all aspects of our clients’ interactions with the Food and Drug Administration. We are closely involved in our clients’ pre-market strategies and their implementation, including those involving product development, investigational device submissions, pre-market notification and approval applications, and lifecycle management. On the post-market side, our FDA attorneys have extensive experience advising on agency inspections and answering inspectional findings; counseling on labeling, advertising, good manufacturing practices and product reporting issues; and helping plan and implement remedial actions.

Our lawyers have a keen understanding as to how the agency works, and assist clients with responding to all agency inquiries, including untitled and warning letters, investigations and enforcement actions. Our FDA lawyers also provide support to clients engaged in corporate transactions, analyzing deal documents, initial public offerings and subsequent disclosures, and conducting due diligence on FDA and related issues in numerous contexts. Additionally, we assist with legislative issues before the United States Congress, including the amendments to the Federal Food, Drug, and Cosmetic Act.

U.S. News - Best Lawyers®

Recognized in national and metropolitan practice areas and ranked in Tier 1 including for work in Real Estate, and Land Use & Zoning.

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Companies facing products liability and mass tort litigation require experienced counsel with a sophisticated, multi-disciplinary practice. At the same time, the stakes for corporate defendants have grown to “bet the company” magnitude in many instances. Companies in these situations count on Goodwin to ensure their interests are optimally protected.

Intellectual property assets represent significant value for businesses in the United States. For some clients, these assets represent an entire career or a body of research; for others, they're a 100-year-old trademark, or a newly acquired license. Whether it’s structuring transactions or resolving high-stakes property disputes, we understand the unique needs of each client, and anticipate how those needs will change over time. With superior experience– from scientists who’ve worked in the field, to litigators with International Trade Commission and federal court experience – we’re privileged to represent national and international companies in a broad cross-section of industries.

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges.

Life Sciences

Products Liability + Mass Torts

Intellectual Property

FDA Litigation