Expertise in all things FDA
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Expertise in all things FDA
Overview
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 Health. Mr. Dormer was responsible for counseling what was then known as the Bureau of Radiological Health, which is now part of FDA’s Center for Devices and Radiological Health. He also represented the FDA in civil and criminal litigation throughout the country. Prior to joining the FDA, he served as an attorney for the White House Special Action Office on Drug Abuse Prevention.
Mr. Dormer regularly counsels pharmaceutical clients on Hatch-Waxman patent and exclusivity issues, orphan drugs, and biosimilar regulation and policy. He also has extensive expertise with post-marketing issues such as advertising and promotion, and good manufacturing practices for drugs and medical devices.
Mr. Dormer is the author of three book chapters on food and drug law as well as numerous published articles. He regularly speaks on food and drug law at legal and regulatory conferences and provides expert testimony.