Overview


Paul Radensky, MD, advises manufacturers at every stage of product development, including the design and monitoring of clinical trials, positioning and applying for Food and Drug Administration (FDA) approval, maintaining regulatory compliance, and obtaining coverage, coding and payment for new technologies by Medicare, Medicaid and other third-party payors. He serves as a principal of McDermott+Consulting LLC.

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Results


  • Obtained a favorable Office of Inspector General (from the Department of Health & Human Services (HHS)) advisory opinion on subsidies provided in the setting of a clinical trial
  • Obtained a new non-proprietary name for an established biological product, which, as a result, set the non-proprietary name stem on the entire family of biologicals
  • Obtained four favorable Medicare national coverage determinations, including the first-ever parallel review

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Recognitions


  • The Best Lawyers in America 2009 to 2019, Biotechnology Law
  • Legal 500 United States, 2019
  • LMG Life Sciences, Life Science Star 2015 to 2016, 2018
  • Chambers USA 2018, Recognized Practitioner

Community


  • Alpha Omega Alpha Honor Medical Society
  • American College of Physicians

Credentials


Education
Harvard Law School, JD, magna cum laude, 1988
University of Pennsylvania, MD, 1979
Princeton University, AB, cum laude, 1975

Admissions
District of Columbia
Florida

Paul W. Radensky, MD

Insights & Events / Media

On the Subject / February 11, 2014

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