James N. Czaban

Wiley Rein LLP

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Recently by James N. Czaban

Food & Beverage

From Farm To Factory To Fork – New FDA Food Safety Rules To Have Monumental Impact On Industry And Consumers

The Food and Drug Administration (FDA) on January 4, 2013, two years after the Food Safety Modernization Act (FSMA) was enacted, proposed two sweeping rules aimed at preventing the contamination of produce and processed foods. These proposed rules represent a monumental change in the way the FDA...

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Biotechnology | Healthcare | Life Sciences

An FDA Practice With Insider Expertise

Editor: Ms. Gunawardhana, please tell our readers about your background at the FDA. Gunawardhana: I started my career at the FDA in 2003, as a regulatory counsel in the Center for Devices and Radiological Health (CDRH) in the Division of Bioresearch Monitoring within the Office of...

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The FDA: Its New Regulatory And Enforcement Emphasis

Editor: Jim, tell us how you developed an interest in regulatory law practice and your current practice. Czaban: I first developed an interest in FDA regulatory law while working with Dick Merrill, the former FDA Chief Counsel and Dean of the University of Virginia School of Law. Dick is one of...

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