Elizabeth Richards, a partner in the Healthcare & Life Sciences Practice, advises clients on all aspects of FDA oversight and regulation.
Ms. Richards helps clients navigate regulatory, compliance, transactional, and legislative matters involving the US Food and Drug Administration (FDA). She also counsels clients on matters involving regulation by the Drug Enforcement Administration (DEA) and the US Department of Agriculture (USDA). Her practice spans all stages of the product life cycle, including with respect to:
- Pre-market product development
- Clinical trials and pre-clinical testing
- Product submissions
- Product marketing, promotion, and labeling
- Good manufacturing practice
- Agency inspections and recalls
- Enforcement actions
Ms. Richards regularly counsels clients in the pharmaceutical, medical device, food, dietary supplement, cosmetic, and other biotechnology industries on regulatory compliance and enforcement matters. With the enactment of the Farm Bill in 2018, she also represents companies seeking to market CBD consumer products to navigate the evolving legal framework governing the industry.
Ms. Richards frequently drafts and negotiates contracts with clinical trial sites, contract research organizations, contract manufacturers and laboratories, and other vendors on behalf of pharmaceutical and medical device company clients. She also regularly advises on regulatory matters in connection with capital markets and M&A transactions involving FDA- and DEA-regulated entities.
Ms. Richards writes and speaks on technical FDA regulatory and enforcement matters, including as part of the Latham Healthcare and Life Sciences Hot Topics video series and at Food and Drug Law Institute-sponsored events.
She currently serves as a member of the Food and Drug Law Institute’s Publications and Academic Programs Committee, and previously served as an Advisory Board member of the Children’s Law Center.
“Legalization of Products Containing CBD? Not Quite Yet, Says FDA 8 May 2019,” Client Alert (May 2019)
- “FDA Announces Planned Changes to the 510(k) Premarket Notification Program,” Client Alert (December 2018)
- “FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding,” Client Alert (August 2017)
- “FDA Issues Draft Guidance on Biosimilar Interchangeability,” Client Alert (January 2017)
- “FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages,” Client Alert (February 2014)
- “The Regulation of Follow-on Biologics,” The Food and Drug Law Institute (December 2013)
- “FDA Issues Draft Guidance on Expedited Review Programs, Including Breakthrough Therapy Designations,” Global Privacy & Security Compliance Law Blog (July 2013)
- “FDA Issues Draft Guidance on ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’” Client Alert (July 2013)