Andrew Shaoyu Chen

Practice Areas

Andrew Shaoyu Chen has over 20 years of experience in food and drug law, including serving as Assistant Chief Counsel at the U.S. Food and Drug Administration, and as Senior Counsel at Amgen. Andrew was born and grew up in China, graduated from Peking University, and is admitted to practice in Washington, D.C.

Leveraging this very unique experience, Andrew has been effectively assisting life sciences companies doing business in China and the U.S. to resolve the most challenging legal and regulatory issues, set out critical strategies and implementation plans, respond to ever-increasing government oversight, mitigate enforcement risks, and successfully conduct product licensing and collaboration, clinical trial, product registration, manufacturing, sales and marketing, pharmacovigilance, and pricing and reimbursement.

Andrew has also been actively assisting, on a pro bono basis, the China National Medical Products Administration and various academic organizations to better understand the U.S. FDA framework, and help the NMPA to further reform and align with the leading international regulatory systems.

Personal

J.D., University of Nebraska College of Law,

LL.B., Peking University