Best Lawyers Near You in Washington, District of Columbia for FDA Law

Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, f...

Brian Burgess is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Brian, who practices law in Washington, District of Columbia, has been recognized since 2024. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Brian is held by other top lawyers in the same geographic and legal practice area.

Life sciences and FDA-regulated companies rely on Brendan Carroll to understand their business, tackle nuanced regulatory issues, and provide practical solutions to meet their business needs as they navigate complex and highly technical FDA laws and regulations. He represents a variety of industry stakeholders engaged in the design and development, manufacture, sale, and distribution of a wide range of FDA-regulated products. General counsel come to Brendan to help them find practical solutio...

Lynn W. Mehler is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Lynn W., who practices law in Washington, District of Columbia, has been recognized since 2023. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Lynn W. is held by other top lawyers in the same geographic and legal practice area.

William M. Jay is a top attorney recognized by Best Lawyers in the practice area(s) of Appellate Practice, Bet-the-Company Litigation, FDA Law and Litigation - Patent. William M., who practices law in Washington, District of Columbia, has been recognized since 2016. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which William M. is held by other top lawyers in the same geographic and legal practice area.

Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, from product approvals to advertising and promotion, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medical device and IVD companies, as well as pharmacies. Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient and insightful guidance. He has wor...

Mr. Scheineson is a partner in the Washington, D.C., office, where he heads the firm’s Food and Drug Law Practice. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies and enforcement. Previously, he served as the associate commissioner for legislative affairs of the Food and Drug Administration. He was involved there in many agency innovations, including prescription drug user fees, debarment, medical device amendments and nutritional...

Julie Tibbets is a partner in Goodwin’s Technology and Life Sciences group and a member of its FDA practice.Ms. Tibbets focuses her practice on FDA-regulated product development, marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product reach spans biologics, drugs, medical devices, in vitro diagnostics, foods, dietary supplements, and cosmetics. Ms. Tibbets advises clients on interactio...

Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications, marketing, and import/export. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective dis...

Cathy Burgess leads the firm’s FDA Compliance and Enforcement Team and FDA practice. FDA-regulated entities benefit from Cathy's common-sense advice for achieving business objectives that avoid compliance and enforcement risks. With more than 30 years of extensive experience in the areas of CGMP regulation and product risk management, she provides strategic counseling and works with clients to identify and address potential risks throughout the product life cycle. Cathy advises clients ...

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters. Rick works extensively with clients on the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings...

Paul M. Hyman is a founding member of Hyman, Phelps & McNamara. Since opening the firm in 1980, he has led efforts to make it the premiere FDA law practice. He brings five decades of perspective to the regulatory priorities and policies of FDA and FTC. Mr. Hyman has advised clients on nearly every aspect of FDA regulation, ranging from premarket approvals, to labeling and post-market compliance, and has defended against enforcement actions such as warning letters, recalls, and court actio...

James N. Czaban is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. James N., who practices law in Washington, District of Columbia, has been recognized since 2015. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which James N. is held by other top lawyers in the same geographic and legal practice area.

Seth Mailhot is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Seth, who practices law in Washington, District of Columbia, has been recognized since 2027. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Seth is held by other top lawyers in the same geographic and legal practice area.

Devon Hill counsels clients on the regulatory issues involved in the global marketing of new foods, cosmetics, packaging, and related products and compliance issues that arise for products already on the market. He has over two decades of experience assisting clients that make food, cosmetics, and materials that contact food. He primarily assists clients with regulatory compliance and safety and policy issues in the United States and most countries around the world. Food and drug packaging cl...

George Misko counsels domestic and foreign clients on food and drug matters. He advises clients on regulatory requirements relating to chemical substances specific to food contact, plastics, and food products in the United States (U.S.) and other jurisdictions, including Canada, the European Union (EU), Latin America, and the Asia-Pacific region. George also has experience in counseling on environmental concerns, including pesticide regulation, right-to-know laws, and toxic substance control ...