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.