Elizabeth M. Richards

Elizabeth Richards advises clients navigating the US Food and Drug Administration’s (FDA’s) oversight and regulation of the life sciences industry, including digital health, medical device, pharmaceutical, biotechnology, dietary supplement, food, cosmetic, and other life sciences industry clients.

Ms. Richards counsels clients on regulatory, compliance, transactional, and legislative matters involving the FDA. Her practice spans all stages of the product life cycle, including with respect to:

• Pre-market product development and launch strategy
• Clinical trials and pre-clinical testing
• Product submissions
• Product marketing, promotion, and labeling
• Good manufacturing practice
• Agency inspections and recalls
• Enforcement actions

In addition to her focus on regulatory counseling and advocacy, Ms. Richards frequently drafts and negotiates contracts with vendors of life sciences clients, including clinical trial sites, contract research organizations, contract manufacturers and laboratories, and suppliers. She also regularly advises on regulatory matters in connection with capital markets, financing, and M&A transactions involving FDA-regulated entities.

She currently serves as a member of the FDLI’s Medical Products Committee and served as an inaugural member of the FDLI Digital Health Committee, and has previously served on its Publications and Academic Programs Committee. Ms. Richards is also a 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, and she participates as a member of the Medical Device Manufacturers Association’s FDA Working Group. Ms. Richards also previously served as an Advisory Board member of the Children’s Law Center. 

Thought Leadership

Ms. Richards regularly writes on technical FDA regulatory, compliance, and enforcement matters. Some of her recent thought leadership includes:

• "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)
• “Cannabis Rethink Sparks PE Interest,” Latham & Watkins Article (January 2022)

Speaking Engagements

Some of Ms. Richards’ recent speaking engagements include:

• “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)