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English 中文
Shaoyu Chen is a member of the firm’s Food and Drug practice group and the managing director of its China food and drug practice. Mr. Chen has over 10 years experience in food and drug law, including serving as assistant chief counsel at the United States Food and Drug Administration Office of Chief Counsel, as senior counsel at Amgen Inc., and as chief compliance counsel for GE Healthcare China. Mr. Chen represents pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetic companies in matters before the China SFDA, the U.S. FDA, and other government agencies. He regularly assists clients on legal and regulatory issues related to SFDA and FDA oversight, including those pertaining to preclinical research, clinical trial, marketing approval, advertising and promotion, manufacturing GMP, pharmacovigilance, import and export, and compliance with Foreign Corrupt Practices Act and China Anti-Unfair Competition Law.
Honors and Rankings
- Chambers Asia, China: Life Sciences (2012)
Publications and Speeches
- "Chinese Government Centralizes Database of Bribery Convictions," Covington E-Alert (2/17/2012), Co-Author
- "Regulation of Innovative Drugs in U.S. and China," Peking University Chinese Course on Drug Development and Regulatory Sciences (November 2011)
- "Learning from FDA Innovative Drug Review and Approval Mechanism," SFDA Seminar on Drug Development and Evaluation (November 2011)
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