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

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...

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...

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...

Peter V. Lindsay is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Peter V., who practices law in Washington, District of Columbia, has been recognized since 2021. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Peter V. is held by other top lawyers in the same geographic and legal practice area.

Gregory H. Levine is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Gregory H., who practices law in Washington, District of Columbia, has been recognized since 2011. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Gregory H. is held by other top lawyers in the same geographic and legal practice area.

Katlin McKelvie is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Katlin, who practices law in Washington, District of Columbia, has been recognized since 2026. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Katlin 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...

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...

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...

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 ...

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...

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...

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...

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.