Medical Devices

Books & Primers

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

By Marc C. Sanchez, Contract In-House Counsel and Consultants, LLC This resource offers an overview of the regulation of food from the p...

Food and Drug Law and Regulation, 3rd Edition

March 2015

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

The Regulation of Medical Devices in Canada

January 2015

Edited by Sara Zboroski, Andy Radhakant, and Andrew Lord, Davis LLP Canada’s regulatory regime for medical devices is rooted in the Medi...

Articles

Update Magazine March / April 2016

March 2016

Contents Letter Letter from the President & CEO Features Managing the Risks Embedded in Embedded Marketing: Five Things Every Manuf...

Update Magazine January/February 2016

February 2016

Contents Letter Letter from the Chair   Features Separating Drugs from Supplements by Jessica P. O’Connell and Miriam Gug...

Food Drug and Law Institute Announces New Board Members

January 2016

  Washington, DC. - The Food and Drug Law Institute (FDLI) welcomes four new exemplary leaders to its board of directors: Jennifer L...

Annual Conference - Submit Your Suggestions

December 2015

We invite you to share your ideas for topics and speakers for the 2016 Annual Conference.

Food & Drug Law Journal

Food and Drug Law Journal Volume 70, Issue 4 2015

February 2016

To purchase articles, go to https://shop.heinonline.org/.   Table of Contents i Rep...

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality, 70 Food and Drug Law Journal 289–314 (2015)

July 2015

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recent...

A Tale of Two Transparency Attempts at FDA, 68 Food and Drug Law Journal, 423-449 (2013)

July 2015

This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transpar...