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Jianyuan Hua


Jianyuan Hua is an associate within the FDA Regulatory Group, where she provides legal representation to life sciences companies, cosmetic manufacturers, food service companies, consumer goods companies and early-stage companies. She specializes in navigating regulatory frameworks governed by the FDA, as well as other government agencies, such as FTC, CPSC, and USDA. 

Her expertise encompasses a broad spectrum of activities throughout the product development lifecycle. This includes advising on various issues ranging from FDA pharmacovigilance regulation to exclusivity considerations for drugs and biologics, post-market commitments, and FDA promotional rules. With a background in biomedical research and bioethics, she leverages her subject matter expertise in the pharmaceutical and medical device industries, helping clients navigate complex and ambiguous regulatory frameworks. Furthermore, Yuan guides companies through FDA Warning Letters, manages product recalls, and handles various compliance and enforcement matters. 

During law school, she interned at the FDA’s Office of the Chief Counsel, the fraud section at the DOJ, and the Southern District of New York, among others. Prior to law school, she worked as a researcher at the National Institutes of Health and Columbia University. 

Bar admissionsNew York


Yuan’s experience includes:

  • Counseled a pharmaceutical company for its post-approval compliance
  • Conducted internal review of pharmacovigilance practices for a global pharmaceutical company
  • Developed policies and procedures governing the use of promotional and non-promotional materials
  • Counseled companies on drug and biologic exclusivity
  • Conducted research analysis for a section 15b report
  • Representing a large pharmaceutical company in federal court in a commercial contract dispute related to the FDA approval process of cell and gene therapy products
  • Represented an insurance company in a representations and warranties dispute related to an FDA-regulated article
  • Conducted medical device and classification analysis of a clinical decision support software for a start-up company
  • Conducted regulatory due diligence and provided legal counsel for an acquisition of a food service distributor
  • Prepared responses to FDA warning letters for unapproved new drug products and dietary supplements
  • Advised a start-up cosmetic company for its product labeling and packaging
  • Chinese (Mandarin)
  • J.D., The Benjamin N. Cardozo School of Law
  • M.S., Columbia University
  • B.S., Cornell University

Memberships And Affiliations

  • Food and Drug Law Institute, member