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Lowell M. Zeta
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Leveraging his experience at high levels of FDA and regulatory practice, Lowell Zeta serves as a key legal and compliance advisor and outside regulatory counsel to life sciences companies on critical matters impacting their essential medicines and product portfolios. Global manufacturers and innovative biotech startups and their investors rely on his strategic guidance and business acumen to find practical solutions through his awareness of critical issues facing the life sciences industry, his on-site experience providing real-time support to manufacturers around the world, and his perspective on intra-agency decision-making and enforcement priorities.
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, focusing on next generation products with complex manufacturing and global supply chain considerations. He is at the forefront of the industry's digital transformation initiatives and advises on AI and enabling technologies and innovative data strategies, drug development tools and innovative biomarkers, real-world evidence (RWE) platforms, advanced manufacturing, and supply chain resilience.
He works closely with executive leadership and risk oversight committees to resolve warning letters and import alerts, and advises on product and compliance-related government and internal investigations, global corporate compliance programs, commercial manufacturing arrangements, and due diligence in life sciences transactions.
He represents FDA-regulated companies in government and commercial litigation involving FDA regulated products, including negotiations with DOJ/FDA regarding injunctions and consent decrees related to product quality and market access issues, legal challenges to agency decisions under the Administrative Procedure Act (APA), and commercial disputes under the Lanham Act and state consumer protection laws.
Credentials
Education
- LL.M., Georgetown University Law Center
- J.D., Creighton University School of Law
- B.A., The University of Iowa
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
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)
Recognition
Events
Hogan Lovells Events
21 November 2024 | 10:00 a.m. - 11:00 a.m. (CST/HKT/SGT) | 11:00 a.m. - 12:00 p.m. (JST) | 1:00 p.m. - 2:00 p.m. (AEDT) | 9:00 p.m. - 10:00 p.m. (EST - Wednesday, 20 November 2024)