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Anna Zhao advises clients on a broad range of regulatory and compliance matters with primary focus in the life sciences industry. Her practice includes providing advice on U.S. and China regulatory matters involving food, drugs, devices, cosmetics, tobacco, and other regulated products. She regularly advises clients on product development and approval, informed consent, expedited programs, regulatory exclusivities, and promotion issues, as well as related legislative advocacy matters.

Food and Drug Regulatory Matters

  • Assisted companies and industry associations in submission of public comments to the U.S. Food and Drug Administration and the National Medical Products Administration of China (formerly China Food and Drug Administration).
  • Counseled businesses on clinical trial issues, drug approvals, and marketing exclusivities.
  • Advised food, pharmaceuticals, dietary supplements, and cosmetics companies on product promotion and labeling issues.
  • Developed compliance policies for pharmaceutical and medical device companies.
  • Conduct internal investigations for pharmaceutical companies on a range of issues such as clinical trial misconduct, promotion and labeling, and data integrity.
  • Advised companies on gene therapy and genetic testing issues.
  • Conducted regulatory due diligence for transaction matters.   

White Collar Defense and Investigations

  • Representation of a major pharmaceutical company in numerous internal investigations concerning sales and marketing practices.   
  • Representation of a major financial institution in government investigations of foreign bribery relating to hiring practices.
  • Representation of an employee at a major bank on issues arising under the False Claim Act.

International Trade and Investment

  • Advised companies and business associations regarding commitments of foreign governments under World Trade Organization (WTO) rules and free trade agreements.
  • Advised a leading payment card association on the WTO dispute settlement proceedings and electronic payment services regulations in China.
  • Assisted various clients in analyzing Chinese government’s approval process and restraints on foreign investment.

Pro Bono

  • Assistance to dual-eligible individuals regarding their Medicare Part D prescription drug benefits.
  • Advice on legal issues relating to intra-state conflicts and peace negotiations in Africa.
  • Representation of deaf and hard-of-hearing inmates in Michigan in The Americans with Disabilities Act (ADA) and constitutional claims.

Memberships and Affiliations

  • American Bar Association
  • New York State Bar Association
  • Association of Certified Fraud Examiners
  • Sino-American Pharmaceutical Professionals Association