Winston S. Kirton chairs Frier Levitt’s FDA Practice. He advises domestic and international companies on regulatory challenges involving products and services regulated by the FDA, including biopharmaceuticals, medical devices, foods, dietary supplements, cosmetics and enabling technologies. His practice centers on corporate transactions, research and development, manufacturing and supply chain, and commercial regulatory and compliance matters. He also counsels clients on business and legal strategies and disputes involving third-party manufacturing relationships, suppliers and strategic alliance partners.
Winston’s depth in complex FDA requirements allows him to guide clients through every stage of FDA regulatory due diligence in their most significant transactions. His experience enables him to help clients navigate both the legal requirements and practical business considerations associated with bringing FDA-regulated products to market and maintaining compliance.
Before entering private practice, Winston built extensive in-house experience at several large multinational biopharmaceutical companies, working across quality and compliance, regulatory affairs, compliance and ethics, and legal affairs. He previously served as assistant general counsel and as the London-based head of compliance and ethics for a multinational U.S. pharmaceutical company, with responsibility for business units across multiple international markets. This in-house background gives Winston a practical understanding of the business realities facing FDA-regulated companies and informs his approach to developing regulatory and compliance strategies.
Winston serves on the Board of Directors of the Food and Drug Law Institute (FDLI), where he began a four-year term in 2026. He has also served on the Food and Drug Law Journal Editorial Review Board and on numerous FDLI conference planning committees.
Insights
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- 06/24/2026 – Innovation and Commercialization Pathway in Gastrointestinal Endoscopy: A Practical Primer from American Society for Gastrointestinal Endoscopy (Gastrointestinal Endoscopy)
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- 08/13/2025 – FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing
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- 01/16/2024 – FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
- 10/23/2023 – FDA Forms Digital Health Advisory Committee to Navigate Emerging Technologies
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- 01/1/2026 – Winston Kirton Appointed to FDLI Board of Directors for a Four-Year Term
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- 11/21/2025 – Winston Kirton Joins 2026 Healthcare Businesswomen’s Association (HBA) Board Nominating Committee
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- 05/28/2025 – Winston Kirton Joins Food and Drug Law Journal Editorial Review Board
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- 11/26/2024 – Winston Kirton Comments on Racial Disparity in Clinical Trials in The American Journal of Managed Care
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- 09/17/2024 – Winston Kirton Participates in Panel on Health Equity at 2024 HBA Annual Conference
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- 05/05/2026 – Regulatory Horizons: FDA’s Current Inspection Focus: What Companies Are Really Getting Cited For
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- 04/07/2026 – Regulatory Horizons: Supply Chain Sovereignty: How U.S. and EU Regulatory Priorities Are Reshaping Life Sciences Manufacturing
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- 03/10/2026 – Regulatory Horizons: What Life Sciences Companies Should Know About the BIOSECURE Act
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- 02/10/2026 – Regulatory Horizons: Cybersecurity and FDA Regulated Companies
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- 01/07/2026 – Regulatory Horizons: AI & Digital Health – FDA Evolving Oversight
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- 10/01/2025 – Winston Kirton Speaks on Panel at WOCIP® 9th Annual Conference
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- 04/25/2025 – Winston Kirton Presents at 2025 Food & Drug Law Institute Annual Conference
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- 01/22/2025 – Winston Kirton Presents at Legal, Regulatory and Compliance Forum on Cosmetics and Personal Care Products
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- 10/21/2024 – Winston Kirton Speaks on Panel at TEDCO’s 2024 Entrepreneur Expo
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- 04/15/2024 – Winston Kirton Co-Chairs 2024 FDLI Annual Conference and Moderates the Panel “Modernizing Clinical Trials: Improving Diversity and Efficiency While Maintaining High Standards.”
