Elizabeth M. Richards

Partner at Latham & Watkins LLP

Elizabeth M. Richards

Elizabeth M. Richards

Partner at Latham & Watkins LLP

Biography

Elizabeth Richards is a partner in the Washington, D.C. office of Latham & Watkins. She advises clients on regulatory and compliance matters involving the US Food and Drug Administration (FDA) at all stages of the biotechnology product life cycle, including:

Pre-market product development and clinical and pre-clinical testing
Product submissions
Regulation of marketing and labeling of products
Compliance with manufacturing practice requirements
Agency inspections and recalls

Ms. Richards regularly works with pharmaceutical, medical device, and other biotechnology companies on contract matters with respect to clinical studies and manufacturing, among other areas. She also frequently advises on regulatory matters in connection with capital markets and M&A transactions involving FDA-regulated entities. Ms. Richards has led presentations on behalf of the Food and Drug Law Institute (FDLI) on FDA regulation at FDA and FDLI-sponsored events. She has authored numerous articles on novel areas of the law, including FDLI-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.

Prior to joining Latham, Ms. Richards interned with the Department of Health and Human Services, Office of the General Counsel, Public Health Division.

Ms. Richards earned her Master of Public Health from the Johns Hopkins Bloomberg School of Public Health. During the program, 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.

Publications



“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“FDA Issues Draft Guidance on Biosimilar Interchangeability,” Client Alert (January 2017)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“FDA Issues Draft Guidance on Expedited Review Programs, Including Breakthrough Therapy Designations,” Global Privacy & Security Compliance Law Blog (July 2013)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)

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Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Counsel at Latham & Watkins LLP

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Office Managing Partner, San Francisco at Latham & Watkins LLP

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Chair, Health Care & Life Sciences Practice at Latham & Watkins LLP

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Global Chair, International Tax Practice at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Partner at Latham & Watkins LLP

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Latham & Watkins LLP is a full-service law firm. The firm offers services in the areas of finance, litigation, tax, banking, life sciences, private equity, real estate, government relations, employment law, and outsourcing. The firm practices in a spectrum of transactional, litigation, corporate, and regulatory areas. Latham & Watkins was established in 1934 and is based in New York, New York.

Intern in Public Health Division, Office of the General Counsel
Prior

The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW).

Transactions
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Checkmate Pharmaceuticals, Inc. issued USD Common Stock

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Vital Farms, Inc. issued USD Common Stock

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Berkeley Lights, Inc. issued USD Common Stock

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