Diagnostics

Books & Primers

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

June 2015

This primer is designed to be an introduction to food law and regulation. Food law is an ever-growing and ever-changing area of law and r...

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 ContentUpdate Magazine May/June 2015

July 2015

Table of Contents  (Coming soon)

Members Only ContentUpdate Magazine March/April 2015

March 2015

Featured Food Labeling Consultations and Modernization in Canada By Martha A. Healey  HIPAA and MOBILE HEALTH APPS: What develop...

Members Only ContentUpdate Magazine January / February 2015

January 2015

Table of Contents Featured Risky Business – On the Trial of Tainted Dietary Supplements by Jason Humbert  Between Two Ev...

Members Only ContentUpdate Magazine November/December 2014

November 2014

Food & Drug Law Journal

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...

The End of “Patent Medicines”? Thoughts on the Rise of Regulatory Exclusivities, 70 Food and Drug Law Journal 39–54 (2015)

January 2015

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown...