Biologics

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

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...

Update 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 and Law Institute Announces New Board Members

January 2016

  Washington, DC. - The Food and Drug Law Institute (FDLI) welcomes four new exemplary leaders to its board of directors: Jennifer L...

Annual Conference - Submit Your Suggestions

December 2015

We invite you to share your ideas for topics and speakers for the 2016 Annual Conference.

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...