Elizabeth M. Richards

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

Liz brings a creative and commercial approach to counseling clients on FDA matters, informed by a clinical background and extensive experience working with and advocating before the FDA.

Liz advises clients across the FDA-regulated industry, from well-established to emerging pharmaceutical, medical device, and biotechnology companies, and in the digital health space from emerging AI/machine learning innovators to tech giants. As a seasoned industry advisor who frequently writes and speaks on complex topics in the FDA bar, Liz is well-positioned to provide pragmatic legal guidance and strategic, business-focused advice.

She helps clients navigate a complex web of FDA regulations across the full product life cycle, from clinical trials to marketing authorization and beyond, including marketing and advertising, inspections, and enforcement actions. An effective advocate, she guides clients through strategic options in pursuing various regulatory paths to market, agency engagement and product development meetings, citizen petitions, regulatory exclusivity opportunities and disputes, and informal and formal appeals. Her deep insight into FDA processes helps clients accelerate development and commercialization to take advantage of regulatory opportunities while complying with regulatory requirements.

Liz collaborates seamlessly with colleagues across practices and borders. Her industry insights facilitate hundreds of transactions annually and drive winning strategies in connection with Administrative Procedure Act litigations, securities litigations, private party disputes, and internal and government-facing investigations.

Liz brings the Healthcare & Life Sciences perspective to Latham’s Artificial Intelligence Practice and the rapidly evolving digital health space.

Outside the firm, she serves on 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.

Speaking Engagements

• “Trump 2.0 and the Anticipated Impact on Industry Investment,” European Healthcare & Life Sciences Investor Symposium (June 25, 2025)
• “Predetermined Change Control Plan (PCCP) Guidance: A Pipeline Towards What?,” FDLI’s Digital Health Technology and Regulation Conference (February 27, 2025)
• “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)