Lowell M. Zeta

Lowell M. Zeta

Counsel
Washington, D.C.

Email lowell.zeta@​hoganlovells.com

Phone +1 202 637 3567

Fax +1 202 637 5910

Practice groupGlobal Regulatory

Combining his experience at the highest level of the Food and Drug Administration (FDA) and private practice, Lowell Zeta excels by providing sophisticated legal counsel to life science companies navigating an ever complex and evolving regulatory landscape.

He rejoins the firm after serving as Senior Counselor to the Commissioner at FDA, where he provided leadership on cross-cutting and high-priority initiatives promoting innovation and addressing public health issues, including the COVID-19 pandemic response.

Emerging and established companies and investors seek his strategic guidance and trusted counsel on critical regulatory issues to advance innovation of medical technology and compliance matters. Core elements of his practice include emerging technologies for precision medicine, current good manufacturing practice (GMP) requirements and drug quality, pharmacovigilance and supply chain surveillance, import and export controls, and FDA inspection and enforcement actions.

At FDA, he was responsible for leading the COVID-19 Pandemic Response and Preparedness Plan (PREPP) initiative to guide the agency's response and future strategic planning. He also led initiatives around clinical trial innovation, fit-for-purpose expedited pathways, Emergency Use Authorizations (EUA), animal and plant biotech regulation, and advanced manufacturing technologies. He worked closely with FDA leadership, the U.S. Department of Health and Human Services, the White House, and Senate and House committees.

He also works with clients on unique regulatory issues involving both FDA and Drug Enforcement Administration (DEA) with regard to controlled substances. This includes issues involving approval of products with Risk Evaluation and Mitigation Strategies to suspicious order monitoring obligations for prescription opioids.

Lowell was a Global Health Scholar with the O'Neill Institute at Georgetown Law, and is a published author on life sciences topics in peer-reviewed journals.

Awards and recognitions

2021

FDA Award of Merit (nominated)
FDA

2017-2020

Food and Drug Law, Rising Star
Super Lawyers

2013-2015, 2017-2018

Health Law, Rising Star
Super Lawyers

2016

Larry M. Simonsmeier Writing Award
American Society for Pharmacy Law

Education and admissions

Education

LL.M., Georgetown University Law Center, 2015

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

B.A., The University of Iowa, 2004

Memberships

Member, American Bar Association

Member, California Life Sciences Association

Member, Food and Drug Law Institute

Member, Parenteral Drug Association

Member, Food and Drug Law Journal Editorial Advisory Board, Food and Drug Law Institute (2016-2020)

Bar admissions and qualifications

District of Columbia

California

Court admissions

U.S. Supreme Court

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

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