Best Lawyers in America for FDA Law
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State
Alan G. Minsk is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Alan G., who practices law in Atlanta, Georgia, has been recognized since 2018. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Alan G. is held by other top lawyers in the same geographic and legal practice area.
Robert E. Slavkin is a top attorney recognized by Best Lawyers in the practice area(s) of FDA Law. Robert E., who practices law in Orlando, Florida, has been recognized since 2021. This recognition is based on an exhaustive peer-review survey, reflecting the high esteem in which Robert E. is held by other top lawyers in the same geographic and legal practice area.
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.
Board Certified by The Florida Bar in Health Law, Martin Dix focuses his practice primarily on pharmacy and drug distribution law. His clients encompass nearly all aspects of the legal drug delivery system, including pharmacies, pharmacists, and pharmacy benefit managers; drug wholesalers; drug and dietary supplement manufacturers; retail medical oxygen dealers; and compressed medical gases wholesalers. He has also represented a variety of other health care providers and entities, such as phy...
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...
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.
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 ...
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.