Lowell M. Zeta
Lowell Zeta focuses his practice on the U.S. Food and Drug Administration's (FDA) regulation of prescription and over-the-counter (OTC) drugs, biologics, and cosmetics. With a strong foundation in litigation and government investigations, Lowell applies his prior experience to guide pharmaceutical and biotechnology companies, research institutions, and health systems on compliance and enforcement issues involving the FDA and other agencies, and in state and federal courts.
Lowell's practice extends to clinical trial design and compliance, advertising and promotion, and manufacturing and post-marketing requirements. He regularly works with life science stakeholders on issues involving FDA inspections, good manufacturing practices (GMP) requirements, import and export issues, and pharmacovigilance responsibilities. He works on investigations concerning off-label promotion, healthcare economic claims, and patient support programs. His practice also includes lifecycle management, such as regulatory exclusivities, bioequivalence, and patent term extension issues.
He started his legal career as a litigation associate in southern California, where he gained significant experience in trial practice and internal investigations. He was selected as a Super Lawyers "Rising Star" in health law and litigation from 2013-2015. He was a Global Health Scholar with the O'Neill Institute for National and Global Health in Washington, D.C. and obtained a Health Law LL.M. and Certificate in U.S. Health Care Law from Georgetown University Law Center. He is a published author on health law issues and he serves as a member of the Editorial Board of the Food and Drug Law Journal.
Areas of Focus
Rising Star, Health Law and Litigation
Larry M. Simonsmeier Writing Award
American Society for Pharmacy Law