Best Washington, District of Columbia FDA Lawyers
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...
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...
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...
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...
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...
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...
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...
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...
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.
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...
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...
Gregory H. Levine is a lawyer recognized by Best Lawyers in the practice area of FDA Law. Gregory H. practices law in Washington, District of Columbia Best Lawyers has recognized Gregory H. Levine since 2011. 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 Gregory H. Levine is held by other lawyers.
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...
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...
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...
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 ...
