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.
Among recent engagements, Paul currently serves as Washington, DC, representative for several coalitions as well as individual companies that are developers of and stakeholders interested in various diagnostic technologies, including advanced laboratory diagnostics, diabetes testing supplies and drug testing systems. He is also policy and reimbursement counsel to global specialty pharmaceutical wound product, diagnostics imaging and pharmaceutical manufacturers.
Paul’s background as a clinical researcher and medical practitioner informs his practical and scientific understanding of product manufacturers and clinical laboratories. He is board certified in internal medicine.
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