Lowell M. Zeta
Associate
Washington, D.C.
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.
Industries
Areas of Focus
Latest thinking and events
Publications
"Institutional Review Board (IRB) Written Procedures" Draft Guidance and NIH's "Single IRB Policy" Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research
Pharmaceutical and Biotechnology AlertPublished Works
Navigating Through a Complex and Inconsistent Regulatory Framework
SAGE JournalsHogan Lovells Publications
Important New Steps in the Evolution of the Federal Policy for Protection of Human Subjects
Pharmaceutical and Biotechnology and Medical Device AlertPublished Works
Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program
70 Food and Drug Law Journal 481Published 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 727View More
