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Lowell M. Zeta

Associate
Washington, D.C.

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.

Education and admissions

Education

  • LL.M., with distinction, Georgetown University Law Center, 2015
  • J.D., cum laude, Creighton University School of Law, 2015
  • B.A., cum laude, University of Iowa, 2004

Memberships

  • Member, Food and Drug Law Institute (FDLI)
  • Member, American Bar Association
  • Member, Los Angeles County Bar Association
  • Member, Orange County Bar Association

Bar admissions and qualifications

  • District of Columbia
  • California

Court admissions

  • U.S. Court of Appeals, Ninth Circuit
  • U.S. District Court, Central District of California
  • U.S. District Court, Eastern District of California
  • U.S. District Court, Northern District of California
  • U.S. District Court, Southern District of California

2013-2015

Rising Star, Health Law and Litigation

Super Lawyers

Latest thinking and events

Published Works

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program

70 Food and Drug Law Journal 481

Published Works

Fundamental First Steps Along the Road to Health Care Reform: Eliminating the Bureaucratic Burdens of Certificate of Need Programs and Embracing Market Competition to Improve State Health Care Systems

41 Creighton Law Review 727
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