Drugs

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...

Bringing Your Pharmaceutical Drug to Market

April 2015

Written by the most experienced drug attorneys in the United States and edited by three distinguished authorities in the field, Bringing ...

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 ...

Articles

Members Only ContentUpdate Magazine May/June 2015

July 2015

Table of Contents  (Coming soon)

Regulating Laboratory Developed Tests (LDTs)

March 2015

Volume 5 Issue 2 of the FDLI Policy Forum – Regulating Laboratory Developed Tests (LDTs) Michelle Bayefsky,National Institutes of ...

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...

Food & Drug Law Journal

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...

Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment, 70 Food and Drug Law Journal 339–369 (2015).

July 2015

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and dia...