Lowell M. Zeta

Lowell M. Zeta

Senior Associate, Washington, D.C.

Email lowell.zeta@hoganlovells.com

Phone +1 202 637 3567

Fax +1 202 637 5910

Practice groupRegulatory

Lowell Zeta guides pharmaceutical and biotechnology companies through their most challenging regulatory battles. He is an effective advocate who works with clients to develop practical approaches to achieve business goals.

His clients rely on his close eye on enforcement trends and emerging legal issues for counsel on Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) compliance and enforcement issues. He helps clients identify compliance risks early and resolve regulatory issues that arise during the development, manufacture, and distribution of drug products.

Lowell has advised clients on issues throughout the product lifecycle, focusing on drug safety and pharmacovigilance responsibilities. These responsibilities include adverse events, safety assessments, monitoring programs, and risk management during clinical research and after products have been brought to market. His experience also involves unique compliance issues involving products approved with Risk Evaluation and Mitigation Strategies (REMS) and controls for manufacturing and distributing controlled substances. He is well-versed in FDA inspections, current good manufacturing practice (GMP) requirements, post-approval changes and management, and import and export issues.

Lowell began his career in California, where he honed his skills in litigation and government investigations. He advanced his career in health law at Georgetown University Law Center where he was a Global Health Scholar with the O'Neill Institute for National and Global Health in Washington, D.C. Lowell is a published author on several life sciences and health law issues including the firm's Focus on Regulation blog, and serves on the Editorial Advisor Board of the Food and Drug Law Journal.

Awards and recognitions

2013-2015

Rising Star, Health Law and Litigation
Super Lawyers

2016

Larry M. Simonsmeier Writing Award
American Society for Pharmacy Law

2017

Rising Star, Food & Drugs
Super Lawyers

Education and admissions

Education

LL.M., Georgetown University Law Center, 2015

J.D., Creighton University School of Law, 2008

B.A., University of Iowa, 2004

Memberships

Member, Food and Drug Law Institute

Member, California Life Sciences Association

Member, Parenteral Drug Association

Member, American Bar Association

Bar admissions and qualifications

District of Columbia

California

Court admissions

U.S. Court of Appeals, 9th 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

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