Washington, DC
Miami
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.
Referenzmandate
- 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
Auszeichnungen
- Chambers USA, Healthcare: Pharmaceutical/Medical Products Regulatory, 2018, 2021-2025
- Best Lawyers in America, Biotechnology and Life Sciences Practice, 2008-2019, 2021-2026
- Thomson Reuters, Stand-out Lawyer – independently rated lawyers, 2023-2025
- LMG Life Sciences, Hall of Fame Inductee, 2021
- The Legal 500 United States, 2019
- LMG Life Sciences, Life Science Star 2015 to 2016, 2018
Praxisgruppen und Fokusthemen
Internationale Märkte
Mitgliedschaften
- Alpha Omega Alpha Honor Medical Society
- American College of Physicians
Qualifikation
Education
- Harvard Law School, JD, magna cum laude
- University of Pennsylvania, MD, cum laude
- Princeton University, AB
Admissions
- District of Columbia
- Florida