Biologics

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 ...

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

Instant Access, Purchase and Download Now By Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP Biosta...

Articles

How Can Policymakers Bridge the Gap Between Precision Medicine and FDA Regulation?

August 2015

Food and Drug Policy Forum Volume 5, issue 7, 2015, August 19, 2015. Peter Huber and Paul Howard of the Manhattan Institute for Poli...

Members Only ContentUpdate Magazine July/August 2015

August 2015

What’s in a Name? Quantifying the Economic Value of Label Information    by Anthony J. Anscombe.......................

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...

Food & Drug Law Journal

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...

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...