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

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...

Members Only ContentUpdate Magazine January / February 2015

January 2015

Table of Contents Featured Risky Business – On the Trial of Tainted Dietary Supplements by Jason Humbert  Between Two Ev...

Members Only ContentUpdate Magazine November/December 2014

November 2014

Biosimilar Nomenclature: Can we Achieve the Truth, the Whole Truth, & Nothing but the Truth?

September 2014

Issue 8 of the FDLI Policy Forum, written by Peter Pitts, focuses on biosimilar nomenclature and recommends that FDA require differential...

Food & Drug Law Journal

Does Sackett Foreshadow the End of Non-Reviewability for FDA Warning Letters?, 68 Food and Drug Law Journal, 241-258 (2013).

August 2013

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedur...

FDA’s Evolving Approach to Nanotechnology, 67 Food and Drug Law Journal, 405-411 (2012).

December 2012

Nanotechnology has emerged as an industry with the potential to change many products regulated by the FDA. While the FDA has been regulat...

Direct-to-Consumer Genetic Testing: Learning from the Past and Looking toward the Future, 67 Food and Drug Law Journal, 413-433 (2012).

December 2012

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to...