Lowell M. Zeta

Lowell M. Zeta

Partner
Washington, D.C.

Email [email protected]​hoganlovells.com

Phone +1 202 637 3567

Fax +1 202 637 5910

Practice groupGlobal Regulatory

Bridging his experience at the highest levels of the FDA and regulatory practice, Lowell Zeta provides sophisticated legal counsel to life science clients on critical regulatory and compliance matters impacting their essential medicines and product portfolios. Innovative startups and global biopharmaceutical companies and their investors seek his strategic guidance on matters that require an integrated analysis of the science, data, and the law.

He counsels extensively on product quality, safety, and compliance with current good manufacturing practice (GMP) requirements and data integrity standards for clinical and commercial stage products, with a focus on next generation products with complex manufacturing and global supply chain considerations. He helps to resolve complicated quality issues, including by advocating for clients before FDA in regulatory meetings, inspection and enforcement action, and government investigations. 

He has deep experience supporting complex contract manufacturing arrangements, including manufacturing services agreements, quality agreements, and safety data exchange agreements. He excels by leveraging his awareness of the pressures facing life science companies, his on-site experience providing clients with real-time support at manufacturing facilities around the world, and his perspective on intra-agency decision-making processes.

He is at the forefront of the industry's digital transformation initiatives, helping to propel drug development programs by navigating evolving regulatory frameworks for digital health technologies, real-world evidence (RWE), novel biomarkers, and patient focused drug development. 

White at the FDA, he served as Senior Counselor to the FDA Commissioner providing leadership on cross-cutting and high-priority strategic initiatives, including the FDA COVID-19 PREPP initiative. He is a published author in peer-reviewed journals, and a public speaker on life science related topics.

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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