Elizabeth Richards

Practice Areas

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.