Biologics

Events

Advertising & Promotion Conference (2016)

September 2016

Members Only ContentAnnual 2016 Highlights

June 2016

Following tradition, the Food and Drug Law Institute’s Annual Conference opened with a keynote address from the FDA commissioner. T...

Introduction to Drug Law and Regulation Course (April 2016)

April 2016

Global Business Conference – Guidance for US Businesses Working Globally

March 2016

Combination Products Workshop – A Comprehensive Overview

December 2015

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 Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

By Coleen Klasmeier and Ryan Kyaat, Sidley Austin LLP Decision making by the Food and Drug Administration (FDA) regularly involves the u...

Articles

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

June 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 ...

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...

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 New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?, 70 Food and Drug Law Journal 243–258 (2015)

July 2015

Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infec...

Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models, 70 Food and Drug Law Journal 315–337 (2015)

July 2015

The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy and quality issues. At t...