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SELECTBIO Conferences Point-of-Care Diagnostics World Congress

James Boiani's Biography

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

James A. Boiani, a Member of the Healthcare and Life Sciences Practice of Epstein Becker & Green, P.C., has over a decade of experience helping clients address complex FDA legal and regulatory issues associated with in vitro diagnostics and other medical devices, drugs, biologicals, and combination products. 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) and PMA reviews), and in post-market compliance matters (e.g., quality systems, product recalls and regulatory reports, import issues, advertising and promotion). James has a particular interest in point-of-care diagnostics and founded the Coalition for CLIA Waiver Reform in May 2014, an industry-health advocate partnership that is dedicated to seeking regulatory and legislative reforms that improve access to point-of-care testing. James was named a 2014 Rising Star in the FDA Legal Practice by Super Lawyers legal rating service. 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.

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CLIA Waiver Reform

Friday, 19 September 2014 at 09:45

Add to Calendar ▼2014-09-19 09:45:002014-09-19 10:45:00Europe/LondonCLIA Waiver ReformPoint-of-Care Diagnostics World Congress in San Diego, California, USASan Diego, California,

FDA’s CLIA waiver process is creating problems for patients, health-care providers, and manufacturers by limiting access to important point-of-care diagnostic tests.  In this session we explore the problems with the process from legal, scientific, and public health perspectives, and propose rational reforms that would improve access to important diagnostics.

Add to Calendar ▼2014-09-18 00:00:002014-09-19 00:00:00Europe/LondonPoint-of-Care Diagnostics World CongressPoint-of-Care Diagnostics World Congress in San Diego, California, USASan Diego, California,