Elizabeth Richards is a partner in the Washington, D.C. office of Latham & Watkins where she is a member of the Healthcare & Life Sciences Practice. Ms. Richards focuses her practice on regulatory and compliance, transactional, and legislative matters involving the US Food and Drug Administration (FDA) at all stages of the biotechnology product life cycle, including:
- Pre-market product development
- Clinical trials and pre-clinical testing
- Product submissions
- Regulation of marketing, promotion, and labeling of products
- Compliance with good manufacturing practice requirements
- Agency inspections and recalls
- Enforcement actions
Ms. Richards regularly counsels pharmaceutical, medical device, food, dietary supplement, cosmetics, and other biotechnology companies on regulatory compliance and enforcement matters. She also 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. Ms. Richards frequently advises on regulatory matters in connection with capital markets and M&A transactions involving FDA-regulated entities.
Ms. Richards has publicly presented on regulatory matters at FDA and Food and Drug Law Institute-sponsored events. She has authored numerous articles on novel areas of the law, including published primers on the regulation of follow-on biologics under the Biologics Price Competition and Innovation Act and the regulation of tobacco products under the Family Smoking Prevention and Tobacco Control Act.
Ms. Richards currently serves as a member of the Food and Drug Law Institute’s Academic Programs Committee, and from 2010 to 2015 she served as an Advisory Board member of the Children’s Law Center.
Prior to joining Latham, Ms. Richards worked as a researcher at the Centers for Law and the Public’s Health, a collaborative institute at Georgetown and Johns Hopkins Universities.
- “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- “FDA Issues Draft Guidance on Biosimilar Interchangeability,” Client Alert (January 2017)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)
- “Medical Device Benefit-Risk Determinations: FDA Releases a Novel Guidance Giving Industry an Inside View of Agency Decision-Making,” Client Alert (April 2012)
- “A Guide to FDA’s Draft Guidance on 510(k)s,” Client Alert (October 2011)
- “Future Medical Device Regulation in the European Union,” Mass Device (October 2011)
- “The Institute of Medicine Recommends FDA Abandon the 510(k) Premarket Clearance Process,” The Bureau Of National Affairs, Inc.’s Medical Devices Law & Industry Report (August 2011)
- “Food Safety in the 21st Century: Strengthening Food Regulation Through Legislative and Administrative Reforms,” Food Safety Magazine (April/May 2011)
- “FDA Revises Informed Consent Regulations to Incorporate Clinical Trial Registration Requirements,” Client Alert (January 2011)
- “FDA Revises Safety Reporting Requirements for Investigational New Drug and Bioavailability and Bioequivalence Studies,” Client Alert (November 2010)
- “The Changing Regulatory Landscape for In Vitro Diagnostic Medical Devices: Increased Scrutiny of Laboratory Developed Tests and the Safety of Personalized Medicine,” The Food and Drug Law Institute’s Update Magazine (September/October 2010)
- “The Web of Clinical Trial Registration Obligations: Have Foreign Clinical Trials Been Caught?” The Food and Drug Law Journal (June 2009)
- “A Brave New World: The US Food and Drug Administration’s Newfound Authority for Regulation of Follow-on Biologics,” Bloomberg Law Reports (April 2010)
- “New Regulations Issued to Implement Incentives for ‘Meaningful Use’ of Electronic Health Records,” Client Alert (February 2010)