Best Lawyers in District of Columbia, United States for FDA Law
Kellie B. Combs is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Kellie B., who practices law in Washington, District of Columbia, has been recognized since 2022. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Kellie B. is held by other top lawyers in the same geographic and legal practice area.
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...
Josephine Torrente’s practice focuses on bringing promising new drug and biological therapies through the FDA approval process. With more than 30 years of experience in the industry, Josephine provides essential regulatory insight and strategic perspective into the pursuit of aggressive objectives. Josephine advises biotech and pharmaceutical senior executives and development teams on strategic direction at critical moments in drug development, from preclinical and Phase 1 matters to co...
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...
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...
With more than 23 years of experience working with the pharmaceutical and medical device industries, Ms. Walsh brings FDA regulatory expertise to clients seeking to achieve their business objectives. She regularly counsels clients facing FDA administrative actions like inspections, warning letters, and recalls. But her passion is helping companies prevent or respond to government investigations, and she conducts internal investigations to achieve compliance and to best position her clients to...
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog , Mr. Karst often leads the response to new rules and regulations, sharing his interp...
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.
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...
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...
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...
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.