Leading Lawyer – Healthcare: Pharmaceutical/Medical Product Regulatory
Chambers USA 2021

Next Generation Partner – Healthcare: Life Sciences
The Legal 500 2020-2021

According to clients:
“Has a strong understanding of the workings of clinical trials and the associated contracts”
“Doesn't hesitate to dive into an issue and works with you to truly understand your needs and business risk portfolio”
Chambers USA 2021

According to clients, “Highly knowledgeable in the practice area and always responds to our inquiries in a timely manner, providing well-thought-out advice at a pace commensurate with our business and our industry”
The Legal 500 2020-2021

Elizabeth M. Richards

Washington, D.C.
  • 555 Eleventh Street, NW
  • Suite 1000
  • Washington, D.C. 20004-1304
  • USA

Elizabeth Richards, a partner in the Healthcare & Life Sciences Practice, advises clients in all facets 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 (FDLI)-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.

Recent Publications
  • “Legalization of Products Containing CBD? Not Quite Yet, Says FDA,” 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)
  • Bar Qualification
    • District of Columbia
    • Maryland
    • JD, Georgetown University Law Center, 2008
      cum laude
    • MPH, Johns Hopkins Bloomberg School of Public Health, 2008
    • AB, Georgetown University, 2004
      summa cum laude
  • Practices
  • Industries
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