It is more important than ever to connect and share ideas. The Law Over Lunch series offers FDLI members the exclusive opportunity to engage in facilitated virtual discussions over lunch on topics of interest to the food and drug law community. This event features unique and co-occurring discussion groups, limited to ten attendees to encourage fruitful conversation. This member-only benefit is a chance to closely learn from, educate, and network with other professionals in the field on new and pertinent topics.
Please only sign up for one discussion as they will take place at the same time.
Table Topics and Facilitators
Synthetic Nicotine – How FDA’s New Authority is Changing the Landscape
Azim Chowdhury, Partner
Keller and Heckman LLP
Food Safety – Regulatory and Technological Trends
Keith A. Matthews, Of Counsel & Amaru Sanchez, Associate
Wiley LLP
ABCs of the ANDA
Sara Wexler Koblitz, Director
Hyman, Phelps & McNamara, PC
AZIM CHOWDHURY is a partner in the food and drug law practice of Keller and Heckman LLP. He is a regulatory and public policy attorney with a focus on vapor, nicotine, and tobacco product regulation. Mr. Chowdhury advises domestic and foreign corporations in matters of Food and Drug Administration (FDA) and international regulatory compliance. In particular, he has developed expertise in tobacco and vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the Tobacco and E-Vapor practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette, and e-liquid manufacturers, distributors, retailers, suppliers, and trade associations in matters of FDA, state, and global regulatory compliance. He also assists corporations in establishing clearances for food and drug additives in the US, Canada, and European Union, with an emphasis on indirect additives used in food-contact materials. Mr. Chowdhury has authored and edited numerous articles and publications. He is a frequent contributor to the Food and Drug Law Institute’s (FDLI) Update Magazine and has served on the Editorial Advisory Board of the Food and Drug Law Journal. In addition, he has been interviewed in the US News and World Report’s Best Lawyers Edition (2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine. Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a BA and BS from Johns Hopkins University, an MBA from the University of Maryland Robert H. Smith School of Business, and a JD, cum laude, from the University of Maryland School of Law.
KEITH A. MATTHEWS has over 25 years of private sector and government experience in environmental law related to chemical substances regulation. He is a former Director of the Biopesticides and Pollution Prevention Division (BPPD) in the US Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP). Prior to becoming Director of BPPD, Keith served in EPA’s Office of General Counsel (OGC), first as a staff attorney, then as an Assistant General Counsel where he supervised attorneys providing legal counsel to programs in EPA’s Office of Air and Radiation, Office of Pesticide Programs, and the Office of Research and Development. Keith’s practice focuses on the regulation of chemical substances, including agricultural chemical and biochemical products, microbial products of biotechnology; and genetically engineered agricultural products that are regulated by EPA, FDA, and the US Department of Agriculture. Keith counsels and advises his clients using his breadth of knowledge on a variety of statutes, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Plant Protection Act, and the National Bioengineered Food Disclosure Standard.
AMARU J. SÁNCHEZ is an associate at Wiley Rein LLP where he counsels domestic and global companies in matters involving products regulated by the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and relevant state agencies. As a former in-house counsel for a publicly traded company, Amaru is well-positioned to help clients navigate complex legal, regulatory, and business issues.
SARA WEXLER KOBLITZ is an associate at Hyman Phelps & McNamara where she advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Ms. Koblitz also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically-modified foods, medical foods, food labeling, and dietary supplement claims and substantiation. Ms. Koblitz has authored several Citizen Petitions and has worked extensively with litigators and experts in preparation for depositions and trial. She has worked with companies of all sizes, from start-ups to fortune 500 companies. Ms. Koblitz also has experience in export control and other areas of regulatory law. Prior to joining Hyman Phelps & McNamara, Ms. Koblitz practiced at a major intellectual property firm, where she counseled clients on the Hatch-Waxman Act and other areas of FDA regulation. Prior to that she worked on general FDA regulatory matters at an AmLaw 100 firm. While in law school, Ms. Koblitz clerked at the FDA Office of Policy and the Humane Society of the United States.April 21, 2022
12:00-1:00 PM ET
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
