Edward L. Korwek is a Senior Partner at the Washington, D.C., law firm of Hogan & Hartson LLP. It is the oldest major law firm in Washington, D.C., with offices around the world. He has a doctorate degree in biochemistry and a law degree, and did his thesis and post-doctoral work in molecular biology. He is a former scientist associated with the National Cancer Institute with a special expertise in biotechnology-derived products. For over two and one-half decades, he has been actively involved in US federal and other proceedings and related matters pertaining to the subject of biotechnology regulation. He has represented major trade associations, non-profit organizations, and many companies on a variety of biotechnology and other matters pertaining to diverse topics such as human and other animal food and drug regulation; human and other animal cloning; orphan drug marketing exclusivity; cell and gene therapy; transgenic plant, animal, and microbial regulation; and FDA, USDA and EPA enforcement matters.
He also has spoken and written extensively on the subject of biotechnology regulation and has been on several U.S. governmental advisory committees, such as the NIH Recombinant DNA Advisory Committee, the U.S. Congress, Office of Technology Assessment Advisory Committee on New Developments in Biotechnology, and two U.S. Agricultural Biotechnology Advisory Committees. He also was a member of the National Research Council, Commission on Life Sciences, Committee on Scientific Principles Underlying Environmental Release Decisions Involving Biotechnology, and the National Research Council Committee on Biotechnology. Dr. Korwek is or has been a member of several advisory boards, including the Food and Drug Law Institute, Biotechnology Law Report, the Food and Drug Law Journal, and the Journal of Biotechnology in Healthcare. He is also a member of several legal and scientific associations, such as the American Bar Association, the Food and Drug Law Institute, the Regulatory Affairs Professional Society, the Drug Information Association, the Environmental Law Institute, the American Agricultural Law Association, the American Association for the Advancement of Science, and the American Chemical Society. He is admitted to practice in Washington, D.C., and before the United States Supreme Court, the District of Columbia Court of Appeals, the United States District Court for the District of Columbia, and the United States Court of Appeals for the District of Columbia Circuit.
Foods--Drugs--Devices--Biologics--Biopesticides--Genetically Engineered Organisms--Cloning--Adventitious Presence--Due Diligence Reviews--Orphan Products
Services
- Food, Drug, Biologics and Medical Device Product Regulation
- Transgenic Organisms/Cloning Regulation
- Plant and Animal Pathogen, Etiologic and Select Agent Regulation
- Orphan Product Regulation/Market Exclusivity Protections
- FDA, USDA, and EPA Enforcement and Compliance Matters
- U.S. Exports and Imports





