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
Could the Administrative Order Process Unlock FDA’s Frozen Rulemaking Process?
John F. Johnson, Of Counsel Shook
Hardy & Bacon LLP
The Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Genevieve M. Razick, Associate
Faegre Drinker Biddle & Reath LLP
COVID-19: Ending a Public Health Emergency
Brigid Bondoc, Of Counsel
Morrison and Foerster, LLP
JOHN F. JOHNSON is counsel at Shook, Hardy & Bacon LLP where he works with companies to develop and implement solutions for complying with the laws administered by Food and Drug Administration (FDA), US Department of Agriculture (USDA), Customs and Border Protection (CBP) and other federal and state agencies. He works with manufacturers, distributors, brand owners, importers and retailers of food, drugs, medical devices, cosmetics and animal products to satisfy their regulatory obligations. John represents companies before FDA and other government agencies subject to inspections or compliance activities, including a judicial action, Warning Letter, Untitled Letter, regulatory meeting, administrative detention, import detention and import alert, and FDA Form 483. Additionally, he helps companies evaluate complaints to determine if a recall is necessary, and if so, he works with clients to manage the product recall to remove the product from market. John counsels clients throughout the product life cycle, including product development and specifications, marketing and labeling, and manufacturing, importation, distribution and sales. This includes determining the possible registrations, permits, licenses and pre-market submissions. Also, he works with clients to create, implement, and maintain internal programs to help foster smooth compliance.
GENEVIEVE M. RAZICK leads clients through the landscape of FDA regulations, particularly pertaining to pharmaceuticals, biologics and medical devices. FDA regulations and pharmaceutical compliance initiatives can require a lot of companies — and Genevieve is poised to help you every step of the way. From annual establishment registration and product listings to product classification, marketing and other compliance issues, she has the knowledge and experience to be your strategic business partner.
BRIGID BONDOC is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of US Food & Drug Administration pre- and post-market regulatory issues. Brigid focuses on medical device, digital health, and in vitro diagnostic companies, as well as other companies whose radiation-emitting electronic products are regulated by FDA’s Center for Devices and Radiological Health. She has advised innovative product developers and manufacturers on key threshold FDA regulatory questions, and regularly advises established life sciences companies on issues such as clinical trials regulation, product approvals and clearances, advertising and promotional claims, and adverse event reporting obligations. Brigid regularly assists clients in developing strategies for approval and marketing and in identifying and mitigating regulatory risks. She also handles challenges to competitor advertising before the National Advertising Division and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. Brigid is a graduate of the University of Tulsa, where she earned her BS in biochemistry before attending law school at Stanford Law School.March 24, 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.
