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Paul Radensky

Partner 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. Paul also advises clinical laboratories on Clinical Laboratory Improvement Amendments (CLIA) and state licensure compliance as well as evolving policies on FDA regulation of laboratory-developed tests. He 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. For further details of Paul' biography, please view McDermott website: https://www.mwe.com/people/radensky-paul-w/ · McDermott Will & Schulte

United StatesClinical Trials, FDA Regulatory Compliance
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About

Partner at McDermott Will & Schulte advising on FDA regulatory compliance, clinical trials, and reimbursement for pharmaceutical, biotechnology, medical device, and clinical laboratory clients. Also advises on CLIA compliance and FDA regulation of laboratory-developed tests.

Practice areas

Clinical TrialsFDA Regulatory ComplianceReimbursementCLIA ComplianceState Licensure ComplianceLaboratory-Developed Tests Regulation

Office

United States

McDermott Will & Schulte · Partner 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. Paul also advises clinical laboratories on Clinical Laboratory Improvement Amendments (CLIA) and state licensure compliance as well as evolving policies on FDA regulation of laboratory-developed tests. He 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. For further details of Paul' biography, please view McDermott website: https://www.mwe.com/people/radensky-paul-w/

United States

Expertise

PharmaceuticalsBiotechnologyMedical DevicesClinical Laboratories

Education

  • MD

Admissions

  • Board Certified in Internal Medicine