Ms. Richards is an attorney in the Washington, D.C. office of Latham & Watkins. Her practice focuses on advising clients with respect to 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
She also frequently works with pharmaceutical, medical device and other biotechnology companies on contract matters with respect to clinical studies and manufacturing, among other areas. A significant portion of her practice is also comprised of capital markets and M&A transactions involving FDA-regulated entities. She has led presentations on behalf of the Food and Drug Law Institute (FDLI) on pharmaceutical and medical device regulation at FDA, and 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 premarket regulation of tobacco products pursuant to 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’s Degree in 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 between Georgetown and Johns Hopkins Universities.
- “FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages,” LW.com (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- “FDA Issues Draft Guidance on Expedited Review Programs, Including Breakthrough Therapy Designations,” Global Privacy & Security Compliance Law Blog (July 2013)
- “FDA Issues Draft Guidance on ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’” LW.com (July 2013)
- “Medical Device Benefit-Risk Determinations: FDA Releases a Novel Guidance Giving Industry an Inside View of Agency Decision-Making,” LW.com (April 2012)
- “A guide to FDA’s draft guidance on 510(k)s,” LW.com (October 2011)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,” LW.com (January 2011)
- “FDA Revises Safety Reporting Requirements for Investigational New Drug and Bioavailability and Bioequivalence Studies,” LW.com (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,” LW.com (February 2010)