Best Lawyers Near You in Washington, District of Columbia for FDA Law
Brian Burgess is a lawyer recognized by Best Lawyers in the practice area of FDA Law. Brian practices law in Washington, District of Columbia Best Lawyers has recognized Brian Burgess since 2024. The Best Lawyers recognition is based on a peer-review survey of lawyers in the same geographic region and legal practice area. The recognition reflects the professional regard in which Brian Burgess is held by other lawyers.
Evangelia (Eve) Pelonis assists clients on U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) matters relating to food, animal feed, food additives and ingredients, and dietary supplements. She helps clients achieve their marketing goals within the relevant legal frameworks and counsels them in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising. Eve helps her clients with issu...
Anthony (Tony) Pavel guides clients through a comprehensive array of food and drug regulatory matters with his extensive knowledge of U.S. Food and Drug Administration (FDA) regulations related to food (including animal food and pet food), food additives and ingredients, dietary supplements, and cosmetics. In addition to FDA matters, Tony assists clients with issues related to the U.S. Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), and other regulatory bodies aroun...
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...
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...
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...
Rachel Bond counsels domestic and international clients on regulatory compliance of food contact materials, as well as cosmetic and drug packaging materials, with the laws and regulations administered by the U.S. Food and Drug Administration (FDA) and its foreign counterparts. With nearly two decades of regulatory experience, Rachel pairs innovative legal and sound scientific strategies to help her clients bring new products to market and achieve broadened markets for their products. She assi...
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...
Michelle L. Butler provides counsel on government pricing, health care, and FDA law in the area of prescription drugs and biologics. Across these practice areas, she specializes in the interpretation of complex regulations. Ms. Butler advises clients on changes in health care law and how these changes affect calculation and reporting across government pricing programs, specifically the Medicaid Drug Rebate Program, the 340B Program, the Medicare Part B Average Sales Price calculation, and the...
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...
Seth Mailhot is a lawyer recognized by Best Lawyers in the practice area of FDA Law. Seth practices law in Washington, District of Columbia Best Lawyers has recognized Seth Mailhot since 2027. The Best Lawyers recognition is based on a peer-review survey of lawyers in the same geographic region and legal practice area. The recognition reflects the professional regard in which Seth Mailhot is held by other lawyers.
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...
Allyson Mullen provides counsel to medical device and in vitro diagnostic (IVD) manufacturers. Ms. Mullen assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. In the premarket area, Ms. Mullen develops regulatory strategy, including obtaining breakthrough device designa...
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 ...
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.
