Best Lawyers Near You in Washington, District of Columbia for FDA Law
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...
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...
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 ...
Robert A. Dormer is one of three founding members of Hyman, Phelps & McNamara, P.C. He has been an integral part of the firm’s growth and expansion in all areas of FDA law. He advises clients on a wide range of issues throughout the product lifecycle including development and approval, compliance, and enforcement. From 1976 to 1979, Mr. Dormer served in FDA’s Office of Chief Counsel. He was an Associate Chief Counsel for Enforcement and Associate Chief Counsel for Radiological...
Frederick (Rick) Stearns provides his clients with experience on a wide range of issues affecting makers of prescription and over-the-counter (OTC) drugs, medical devices, dietary supplements, cosmetics, food, and food ingredients. He is also deeply involved with the regulatory issues surrounding cannabis and hemp-based products, including cannabidiol (CBD) and related cannabinoids. Rick helps manufacturers evaluate the need for marketing approval from the U.S. Food and Drug Administration (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.
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...
Douglas B. Farquhar has more than 30 years of experience as a prosecutor and defense and regulatory attorney. Since joining the firm in 1997, he has advised pharmaceutical and medical device manufacturers and wholesalers, compounding pharmacies, and individuals on a wide range of enforcement activities, including consent decrees, criminal investigations, debarment issues, arbitration proceedings, civil seizures, FDA inspection issues, and injunctions. Mr. Farquhar has a broad-based understand...
As a former trial attorney for the DOJ, Dan knows the complexities of federal court litigation with federal agencies. He litigates cases for companies facing adverse regulatory initiatives or enforcement actions by agencies like the FDA. Dan Jarcho represents clients in federal trial court and appellate litigation involving federal regulatory issues. Dan has litigated numerous Administrative Procedure Act challenges to federal agency actions, including cases involving the U.S. Food and Drug A...
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests. Ms. Javitt’s experience prior to joining Hyman, Phelps & McNa...
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...
Our Methodology
Recognition by Best Lawyers is based entirely on peer review. Our methodology is designed to capture, as accurately as possible, the consensus opinion of leading lawyers about the professional abilities of their colleagues within the same geographical area and legal practice area.
The Process
Best Lawyers employs a sophisticated, conscientious, rational, and transparent survey process designed to elicit meaningful and substantive evaluations of the quality of legal services. Our belief has always been that the quality of a peer review survey is directly related to the quality of the voters.