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SELECTBIO Conferences Point-of-Care Diagnostics, Global Health & Biosensors 2019

James Boiani's Biography



James Boiani, Partner, Epstein Becker & Green, P.C.

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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Revisiting the Point of Care – Changes to FDA Policies on CLIA Waivers and Opportunities in POCT

Wednesday, 9 October 2019 at 08:30

Add to Calendar ▼2019-10-09 08:30:002019-10-09 09:30:00Europe/LondonRevisiting the Point of Care – Changes to FDA Policies on CLIA Waivers and Opportunities in POCTPoint-of-Care Diagnostics, Global Health and Biosensors 2019 in Coronado Island, CaliforniaCoronado Island, CaliforniaSELECTBIOenquiries@selectbiosciences.com

There have recently been substantial changes for the better in U.S. FDA’s approach to application of CLIA Waiver standards, reflected in new FDA guidance.  Mr. Boiani – a seasoned life sciences attorney and the Founder and General Counsel of the Coalition for CLIA Waiver Reform – will offer his perspectives on FDA’s new approach, the history of its evolution and legal underpinnings, and the opportunities it creates for innovation in the U.S. market.  He will cover key elements of new FDA guidance, including use of agreement studies, human factors evaluations, and dual marketing and CLIA waiver submissions, which could make for a more efficient and accepting regulatory environment.


Add to Calendar ▼2019-10-07 00:00:002019-10-09 00:00:00Europe/LondonPoint-of-Care Diagnostics, Global Health and Biosensors 2019Point-of-Care Diagnostics, Global Health and Biosensors 2019 in Coronado Island, CaliforniaCoronado Island, CaliforniaSELECTBIOenquiries@selectbiosciences.com