Drugs

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...

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 Content2016 Annual Conference: Top Food and Drug Cases, 2015 & Cases to Watch, 2016

May 2016

As in years past, one of the most popular sessions at FDLI’s Annual Conference brought law professors and practitioners together to...

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 ...

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...

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program

January 2016

The 340B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discou...

Do We Need Stronger Sanctions to Ensure Legal Compliance By Pharmaceutical Firms? 70 FOOD AND DRUG LAW JOURNAL 435-452 (2015)

December 2015

The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that miscond...