Biography

JESSIKA TUAZON is an Associate in the Health Care and Life Sciences practice, in the San Diego office of Epstein Becker Green. Her practice focuses on drug and device, food, and life sciences law.

Ms. Tuazon’s experience includes:

  • Counseling clients on compliance and regulatory issues involving over-the-counter and homeopathic drugs, devices for human and veterinary use, food products, dietary supplements, and cosmetics
  • Preparing medical device premarket submissions, including identifying predicate devices, developing intended uses and claims, and ensuring compliance with U.S. Food and Drug Administration (FDA) guidance and requirements
  • Providing clients risk-based assessments of viable marketing pathways based on their business strategies and marketing priorities, as well as the product’s regulatory classification, intended uses, claims, and technology
  • Advising clients on issues pertaining to premarket clearance and approval for products regulated by FDA, as well as the associated risks and implications on business operations, product development, labeling, and advertising
  • Helping clients ensure that their advertising, marketing, social media, and promotional activities are fully compliant with all FDA, Federal Trade Commission (FTC), and state regulations and policies
  • Reviewing product labeling, including evaluating criteria for substantiation and structure/function, health, disease, and nutrition claims
  • Counseling clients on issues of liability related to advertising, off-label promotion, and fraud and abuse, including violations of the Food, Drug, and Cosmetic Act (FDCA), the FTC Act, the False Claims Act, the Lanham Act, and the Anti-Kickback Statute
  • Drafting and submitting responses to requests for additional information or investigations of deficiencies, warning letters, and petitions to FDA to exercise market discipline to protect a client’s interests and leverage the impact of regulatory sanctions against competitors
  • Advising on the regulations and laws governing blood banks, medical tourism, and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
  • Counseling clients on compliance with laws, good clinical practices, and other regulations applicable to clinical research, including human subject protection, informed consent procedures, and institutional review boards
  • Preparing protocols and documents for research activities, including Health Insurance Portability and Accountability Act (HIPAA) confidentiality agreements, informed consent forms, Investigational New Drug Application transfer agreements, and other related contractual and transactional matters
  • Assisting clients with establishment registration and listing requirements, compliance with current good manufacturing practices (cGMPs), and issues related to the importation and exportation of products

Before joining Epstein Becker Green, Ms. Tuazon was a food, drug, and life sciences attorney at a law firm in Miami. While attending law school, she was a Law Clerk in the General Counsel’s office of the Florida Agency for Health Care Administration.

Education

  • University of Miami School of Law (J.D., 2012)
  • University of Southern California (B.A., magna cum laude, 2009)

Bar Admissions

  • California
  • Florida

Memberships

  • American Bar Association
    • ABA Food, Cosmetics, and Nutraceuticals Committee, Website Content Editor