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FDA Group

Our FDA practice, located in Washington, D.C., provides counsel, representation and strategic advice to companies subject to the Federal Food, Drug, and Cosmetic Act. Our clients include life sciences companies at all stages of development— including medical device manufacturers, biopharmaceutical companies, and combination product developers. Our practice covers all aspects of our clients’ interactions with the Food and Drug Administration. We are closely involved in our clients’ premarket strategies and their implementation, including those involving product development, investigational device submissions, premarket notification and approval applications, and lifecycle management. On the postmarket 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.

Among our attorneys are two former FDA Associate Chief Counsels, one for medical devices and enforcement, and the other for biologics. 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.[[Read More Delimiter]]

Our FDA attorneys have the experience required to analyze complex situations and propose creative and successful approaches to resolve regulatory issues. We have optimized outcomes for clients by turning back a published FDA announcement of reclassification, appealing not substantially equivalent determinations and addressing agency suggested recall situations, where recall was an inappropriate remedy.

Our FDA group strives to work constructively with the FDA with a focus on creativity, positive engagement, cooperation and skill.