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John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, 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 State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) 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.

  • Assisted business associations with drafting and submission of comments on draft legislation and regulations to National Medical Products Administration.
  • Developed policy papers on regulatory developments in China, related to drug regulation and infant formula regulation.
  • Developed briefs and regulatory submissions for multi-national companies to respond to enforcement inquiries and over one hundred processional consumer cases related to labeling and formulation issues.
  • Advise on digital health regulatory issues, including mobile app registration and telemedicine.
  • Assist food, animal health, drug and medical device companies with regulatory due diligence on M&A deals and on distribution and collaboration partners.
  • Advise on GxP compliance for drug and device companies, including on China-U.S. cross-border aspects of clinical trials.
  • Advised on China e-commerce regulatory compliance for cosmetics, food and health food products.
  • Advise on standard operating procedure and other strategies to protect trade secrets in the drug and device development process in China.

Pro Bono

  • Developed policy paper on hate crime legislation in Asia, South Asia, and the U.S. for use in aiding legislators in other countries in creating comparable schemes.
  • Represented incarcerated individual in completing name change proceedings.

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.