Best Lawyers in District of Columbia, United States for FDA Law
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...
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...
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.
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...
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...
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...
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...
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...
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.
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...
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...
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...
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...
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.