Networking and Insights: A Practical Look at Practicing FDA Law
July 14, 2026 | 5:00PM – 7:30PM | In-Person Event
This special event will bring together NFLR Group members for an engaging conversation with experienced FDA law professionals, featuring panelists from FDA, industry, and law firms. Panelists will share insights into their career paths, discuss the realities of their day-to-day practice, and offer practical guidance for early-career professionals looking to grow their skills and build their portfolios. Following the panel, attendees will have the opportunity to connect with speakers and fellow members at a rooftop networking reception with a view of the Washington Monument that will include hors d’oeuvres and beverages. Don’t miss this valuable chance to gain career insights, expand your professional network, and make meaningful connections in an informal setting.
James Allred
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Senior Counsel, Office of the Chief Counsel (OCC), FDA
JAMES ALLRED is Senior Counsel for Litigation for the U.S. Food and Drug Administration’s Office of Chief Counsel, where he litigates civil cases across product areas on behalf of the agency. His focus has been on defending FDA in cases brought under the Administrative Procedure Act and the US Constitution, and he also handles civil enforcement matters brought under the Food, Drug, and Cosmetic Act in coordination with Department of Justice attorneys. James is admitted as a Special Assistant United States Attorney, allowing him to present argument on behalf of the United States in federal court. He also reviews the work of other civil litigators in the office. James has published a book chapter on Transgenic Plants in the Research Handbook on Intellectual Property and the Life Sciences (Edward Elgar, 2017). He also won the Thomas M. Austern writing prize from the Food and Drug Law Institute (2013). Since joining FDA, he has received the HHS OGC Outstanding Newcomer Award (2023), the FDA Office of the Commissioner Outstanding Service Award (2022), and multiple FDA team and group awards.
Sonali P. Gunawardhana
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, Assistant General Counsel, Regulatory Law, Becton Dickinson (BD)
SONALI GUNAWARDHANA is Assistant General Counsel at Becton, Dickinson and Company (BD), a global medical device company. She also serves as an adjunct professor at American University Washington College of Law.
Prior to joining BD, Sonali held senior in-house legal roles at leading healthcare companies, including Assistant General Counsel, Regulatory Law at Cardinal Health and Chief Counsel, FDA and Regulatory Law at McKesson. Earlier in her career, she was in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP, where she advised a broad range of pharmaceutical and medical device companies on complex regulatory matters.
Sonali began her legal career at the U.S. Food and Drug Administration (FDA), where she served for nearly a decade as Regulatory Counsel. During her tenure, she worked on a wide range of legal and policy issues across multiple FDA centers, including the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Food Safety and Applied Nutrition (CFSAN).
She is actively engaged in the food and drug law community and currently serves on the Food and Drug Law Institute (FDLI) Forward Committee. She previously served on FDLI’s Board of Directors.
Michael B. Jordan
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Associate, Troutman Pepper Locke LLP
MICHAEL B. JORDAN is an associate at Troutman Pepper Locke in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group as well as its Tobacco + Nicotine practice. He draws on a diverse range of experiences in government and private practice to help clients navigate complex regulatory issues, focusing primarily on heavily regulated industries such as tobacco, nicotine, and cannabis. Representing clients in government investigations and enforcement actions, Michael proactively counsels them on all aspects of federal and state regulatory compliance. He advises companies at every level of the supply chain, including manufacturers, importers, exporters, distributors/wholesalers, and retailers, including online retailers. Michael guides clients through a wide variety of federal, state, and local issues, ranging from questions related to licensure and permitting, excise taxes, sales and use taxes, pre-market authorization requirements, and advertising and marketing restrictions. His deep understanding of the laws and regulatory requirements enforced by the U.S. Food and Drug Administration (FDA), Alcohol and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol, Tobacco, and Firearms (ATF), the Federal Trade Commission (FTC), and state taxing and licensing authorities makes him an invaluable asset to his clients. In addition to his regulatory practice, Michael maintains an active pro bono practice. He represents asylum seekers in removal proceedings before the Executive Office for Immigration Review and assists veterans in seeking upgrades to their discharge status to obtain veterans’ benefits.
Moderated by
Sally Gu
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Partner, Hogan Lovells US LLP
Registration
This program is exclusively available to FDLI members who are a part of the New to FDA Law & Regulation Group (NFLR), and student members.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to FDA Law & Regulation Group
NFLR offers young professionals with up to six years of experience an opportunity to connect with colleagues in the food and drug legal and regulatory community, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Kelsey Kerr.
Leah Berhane, FDA – OND
Mara M. Burr, Georgetown University
John Daley, Saluda Medical
Claire Dennis, Arnold & Porter LLP
Laura Dona LaBrie, Arnall Golden Gregory LLP
Jaclyn Fonteyne, Sidley Austin LLP
Sally Gu, Hogan Lovells US LLP
Heather Johnson, Otsuka America Pharmaceutical, Inc.
Michael B. Jordan, Troutman Pepper Locke
Anton Lesaca, Latham & Watkins LLP
Oluwaremilekun O. Mehner, Akin
Catherine A. Melfi, Omeros Corporation
Sydney Menack, Morgan, Lewis & Bockius LLP
Tariq Naeem, Tucker Ellis LLP
Laura Schwendeman, Kleinfeld, Kaplan & Becker, LLP
Hogan Lovells US LLP
555 13th St NW
Washington, DC 20004
Please contact Kelsey Kerr with any accessibility requirements or dietary restrictions, or for other questions.
