Elizabeth M. Richards

Elizabeth (Liz) Richards advises clients on complex FDA regulatory strategy at the intersection of life sciences and cutting-edge technology. 

Liz counsels market-leading global clients on bet-the-company regulatory, compliance, transactional, and legislative matters involving the FDA. She brings a creative and commercial approach, informed by a clinical background and extensive experience working with and advocating before FDA regulators and legal counsel. 

She advises clients across the industry spectrum, from well-established pharmaceutical, medical device, and biotechnology companies to tech giants and emerging companies and startups with novel products. As a seasoned industry advisor who frequently writes and speaks on FDA topics, Liz is well-positioned to provide pragmatic guidance on unprecedented issues and evolving regulations. 

Liz helps clients navigate the full product life cycle, from product development and clinical trials to advertising, inspections, and enforcement actions. She collaborates seamlessly with colleagues across practices and borders to bring substantive industry insights to facilitate transactions and winning litigation strategies, and to achieve her clients’ business objectives and dislodge regulatory obstacles. 

Liz is a founding member of Latham’s Artificial Intelligence Task Force and the firm’s Digital Health Steering Committee, bringing together subject matter experts tracking developments in the rapidly evolving digital health space. 

Outside the firm, she serves as a founding member of the Food and Drug Law Institute’s (FDLI’s) Digital Health Committee and on FDLI’s Medical Products Committee. Liz is also a member of the Medical Device Manufacturers Association’s FDA Working Group and AI Working Group. 

Thought Leadership

Liz regularly writes on technical cutting-edge FDA topics. Her recent thought leadership includes:

• “Healthcare & Life Sciences Market Update,” Latham & Watkins Resource (April 2024)
• “Recent Updates on Emerging Trends in the Global Regulation of Digital Health: Fragmented Frameworks Continue Striving to Catch up with Technological Advancement,” ICLG – Digital Health 2024 (February 2024)
• “Shooting for the Moon: The Evolution of Key AI/ML Regulations Governing Certain Health Care Products and Services,” American Health Law Association (August 2023)
• “Emerging Trends in the Global Regulation of Digital Health: Fragmented Frameworks Aiming to Catch up with Technological Advancement,” International Comparative Legal Guides: Digital Health 2023 (March 2023)
• “The Reproductive Sector – Fertile Ground for PE Deals,” Latham & Watkins Article (May 2022)

Speaking Engagements

Liz’s recent speaking engagements include:

• “Leveraging AI in Medical Device and Drug Development, Diagnostics and Clinical Trials,” ACI’s 11th Annual Summit for Women Leaders in Life Sciences Law (July 26, 2024)
• “Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations,” ACI’s 42nd FDA Bootcamp (March 12, 2024)
• “2024 FDA Outlook: Healthcare & Life Sciences,” Latham & Watkins, We’ve Got Washington Covered (February 21, 2024)
• “Exploring the Regulatory Terrain of Decentralized Clinical Trials,” Current Developments in Digital Health Technology and Regulation Conference (February 1, 2024)
• “Spotlight on the ‘FemTech’ Revolution: Examining the Latest Technological Advancements and Legal Challenges in The Digitalization of Women’s Health,” Women Leaders in Life Sciences Law (July 26, 2023)
• “Diagnostics Regulation and Regulatory Reform,” 2023 FDLI Annual Conference (May 18, 2023)
• “Tailoring Marketing and Claims to the Post-Emergency Use Authorizations Era,” Advertising and Promotion for Medical Products Conference (October 15, 2021)