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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.
Save the Date for these upcoming programs
Introduction to Drug Law and Regulation
June 22-23, 2010 | Westin City Center Hotel
Washington, DC
Advertising & Promotion for the Pharmaceutical,
Medical Device, Biologic and Veterinary Medicine Industries Conference
September 20-21, 2010 | Capital Hilton Hotel
Washington, DC
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.
While each resource center will, of course, differ in content, in general, it will contain the following... Read more.