Resources



Primers

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer by Marc C. Sanchez
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Books

Bringing Your Pharmaceutical Drug to Market by Ralph Hall, Matt Hill, Neil Di Spirito
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Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition by Edited by Mark Carlisle Levy
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Conferences

What You Need to Know About the FSMA Final Rules: Preventive Controls for Human Food by FDLI
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What You Need to Know About the FSMA Final Rules: Preventive Controls for Animal Food by FDLI
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Food Advertising and Litigation by FDLI
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Conference CDs

Introduction to Food Law and Regulation : Understanding How the Government Regulates the Food Industry – PowerPoint presentation with live audio by FDLI
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An Exploration of Ethical Issues Raised by Stevens, Stryker Biotech and Similar Cases Audio by
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2012 Annual Conference: Address from the Office of Chief Counsel, Former FDA Chief Counsels Roundtable Audio by
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Update Magazine

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...

Policy Forums

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...

Reply to Professor Sugarman

June 2015

This special edition of the Food and Drug Law Institute’s Food and Drug Policy Forum features a response to an earlier article...

Finding the Right Benefit-Risk Balance in U.S. Sunscreen Regulation

June 2015

FDLI’s Food and Drug Policy Forum May 2015 issue, “Finding the Right Benefit-Risk Balance in U.S. Sunscreen Regulat...

Food and 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...

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality, 70 Food and Drug Law Journal 289–314 (2015)

July 2015

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recent...

Whitepapers

Viewpoints on FDA: Enforcement

October 2009

Viewpoints on FDA: Enforcementis an invaluable resource for attorneys, manufacturers, consultants and other food and drug stakeholders, w...

FDLI Colloquium Series White Paper #1: Whose Life Is It, Anyway? Abigail Alliance at the Crossroads

January 2008

A tough question - but one that FDA, pharmaceutical manufacturers, physicians, patients and the courts now are urgently trying to answer....

FDLI White Paper #2: Transcript: From Abigail to Pelelope: Individual vs. Corporate Rights

January 2008

Second in a series of discussion on should terminally ill patients get access to unapproved drugs? Now Available Full Transcript from ...