Welcome to FDLI
The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
FDA's (Emerging) Oversight of Laboratory-
Developed Tests
August 4 | 12:30–2:00 p.m. ET | Webinar
Laboratory-developed tests (LDTs) are playing an increasingly large role in diagnostics. The U.S. Food and Drug Administration (FDA) announced that it will start to regulate LDTs. FDA recently held a two-day public meeting to get stakeholder input on how the agency...Read more.
FDLI Announces New Committee for Tobacco Products
FDLI's new Tobacco Committee will advise FDLI staff in developing and implementing policies and strategies to deliver educational meetings, publications, and other services, about law, regulation and policy affecting tobacco products. With the Committee's help, FDLI looks forward to continuing to provide a neutral forum where the challenging and important issues coming from the Family Smoking Prevention and Tobacco Control Act can be openly and thoroughly discussed and debated. This committee, led by co-chairs Nancy L. Buc, Catherine Lorraine, and Beverly Chernaik, will be an integral part of this work. View the Tobacco Committee listing now.
November 8-9 | Park Hyatt Washington | Washington, DC
This is the premier course to help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. By attending this two day program, you will learn the essential elements of the laws and regulations that affect you in the drug industry. From the definition of "drug" to the different regulatory schemes for over-the-counter (OTC) and... Read more.
Upcoming FDLI Programs
Mark your calendars for FDLI's upcoming programs. Registration will be opening soon!
Enforcement and Litigation Conference:
FDA Enforcement—More Individuals, More Often
October 12-13 | Washington, DC
Introduction to Medical Device Law and Regulation:
A Program on Understanding How the Government
Regulates the Medical Device Industry
November 15-16 | Costa Mesa, CA
Hot Topics in Food and Drug Law and Regulation
In Cooperation with Orange County Regulatory
Affairs Discussion Group (OCRA)
November 17 | Costa Mesa, CA