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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.
What is the Status of Custom Devices Regulation after Endotec?
March 29 | 1:00 – 2:30 p.m. ET
Webinar
With the Endotec case as the first custom medical device case in years, and perhaps only the second in history, what is the status of custom device regulation? FDA has never promulgated regulations or guidance on custom devices, leaving industry with little clarity regarding the agency's regulatory approach. The speakers will review the statute, interpret Endotec and explore FDA's potential regulatory response. Read more.
Introduction to Drug Law
and Regulation
June 22-23 | The Westin Washington, DC City enter
Washington, DC
This is the premier course to help you and your organization understand FDA regulations for drug products. 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 prescription (Rx) drugs, this meeting walks you through the major statutory provisions and regulations, and helps you... Read more.
Members Only Resource Centers
Tobacco Law, Regulation & Policy
Resource Center updated March 9
Learn more
To serve our members better, FDLI is creating a series of online Members Only Resource Centers. These resource centers will be one-stop repositories of information and data on cutting-edge food and drug law issues. Read more.