Diagnostics

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 ...

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

April 2014

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the developme...

Articles

Members Only Content2016 Annual Conference: Honorable Royce C. Lamberth Video

May 2016

At FDLI’s recent 2016 Annual Conference, The Honorable Royce C. Lamberth, offered candid insight into the Vascular Solutions case....

2016 Annual Conference: FDA Commissioner Robert M. Califf's remarks

May 2016

“…there are few events that encompass such a longstanding tradition and offer as important and meaningful an opportunity to ...

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...

Members Only ContentUpdate 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 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...

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...

The Limits of FDA’s Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing, 70 Food and Drug Law Journal 259–287 (2015)

July 2015

The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ hig...