500 North Capitol Street, N.W.
Washington, District Of Columbia 20001
United States
Paul Radensky, M.D. is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., and Miami offices. Paul also serves as a principal of McDermott+Consulting LLC. Paul is co-chair of the Firm's Health Services and Medical Products Government Strategies team and a member of the Health Industry Advisory Practice Group.
Paul is a recognized authority on the full range of legal, regulatory and reimbursement issues pertaining to pharmaceutical, biotechnology, medical device, and clinical laboratory development and marketing. His background as a clinical researcher and medical practitioner informs his practical and scientific understanding of both product manufacturers and clinical laboratories. He advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for FDA approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third party payors. Paul also advises clinical laboratories on CLIA and state licensure compliance as well as evolving policies on FDA regulation of laboratory-developed tests.
Paul is ranked in The Best Lawyers in America (2009-2013).
Paul is board certified in internal medicine and is a member of the American College of Physicians and the Alpha Omega Alpha Honor Medical Society. He is a member of the District of Columbia Bar as well as the Florida Bar.
Areas of Practice | 1) FDA - Life Sciences, 2) Health, 3) Health - Product Regulation, 4) Health Care Law Reform, 5) HIPAA, 6) Life Sciences, 7) Life Sciences - Health, 8) Life Sciences - Regulatory, 9) Products Outcomes Research and 10) Reimbursement/Fraud & Abuse |
Law School | Harvard Law School (J.D., 1988) |
Admitted Year | 1988 |
Education | University of Pennsylvania (M.D., 1979); Princeton University (A.B.,1975) |
Bar Member / Association | District of Columbia Bar Association, Florida State Bar Association |
Most recent firm | McDermott Will & Emery LLP |
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Ms. Fitzgerald represents employers in a wide range of industries, including the entertainment, financial services, hospitality, manufacturing, retail, and transportation industries.