John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, and other regulated products. Mr. Balzano has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the China Food and Drug Administration and other agriculture, animal and health care products and services.
He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.
He also advises companies and industry associations on their advocacy strategies, including the notice and comment process before Chinese agencies, and understanding macro policy issues.
Mr. Balzano has particular experience in the U.S. advising on import and export issues, regulation of over-the-counter drug products, and requirements for the acquisition and transfer of biospecimens for research purposes.
- Washington University School of Law, J.D., 2004
- Washington University, M.A., 2004
- Columbia University, B.A., 2001
Judicial Clerkship :
- Hon. Joette M. Katz, Supreme Court of Connecticut, 2007 – 2008
- Hon. Steven M. Gold, U.S. District Court, Eastern District of New York, 2006 – 2007
Bar Admissions :
- New York
Representative Matters :
- Assisted business associations with submission of comments on draft legislation and regulations to China Food and Drug Administration.
- Developed policy papers on regulatory developments in China, related to good manufacturing practices for infant formula and U.S.-Chinese bilateral dialogues.
- Developed advocacy strategy for client related to medical devices and mobile apps.
- Assisted device manufacturer with strategy for clinical development and regulatory approval for domestically manufactured devices in China.
- Assisted client with developing a strategy to meet U.S. and Chinese regulatory requirements for exporting drugs to China.
Previous Experience :
- Prior to joining the firm, Mr. Balzano taught Chinese law and transnational litigation at Boston University Law School. He was also a fellow, and then a senior fellow and a lecturer in law, at the China Law Center of Yale Law School, where he worked with Chinese officials from central and local government agencies and academics on cooperative projects related to the drafting of legislation and regulations in China, primarily in the areas of administrative law and food and drug law.
- Mr. Balzano was in private practice in New York as a litigator from 2008-2010, where his experience included representing companies in transnational litigation.
- In 2004, he was an intern to Rep. Takashi Shinohara in the Japanese House of Representatives.
Rate : $$$