James Boiani,
Partner
James A. Boiani, MS, JD is a Partner in the Healthcare and Life Sciences Practice of Epstein Becker & Green, P.C., where he helps clients navigate complex issues associated with the regulation in vitro diagnostics and other medical devices, drugs, biologicals, combination products, and laboratory developed tests. He has helped clients navigate FDA challenges during product development (e.g., negotiating trial design issues with FDA), the regulatory review process (e.g., 510(k), CLIA waiver, and NDA reviews) and associated regulatory strategies, and in post-market compliance matters (e.g., quality systems, product recalls and regulatory reports, import issues, advertising and promotion). He also counsels testing services providers and a variety of investors with an interest in the life sciences. Mr. Boiani also is the Founder and General Counsel of the Coalition for CLIA Waiver Reform, an organization that has successfully advocated for changes in FDA policies that will improve access to safe, effective, and innovative waived testing for patients at pharmacies, clinics, urgent care centers, and physician offices. Prior to entering the legal profession, James earned degrees in chemistry from MIT and Cornell University, and worked as an environmental consultant on chemistry and regulatory issues, including development and U.S. EPA approval of industry-developed tests for water quality.
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