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

Introduction to Food Law and Regulation: Understanding How the Government Regulates the Food Industry (February 2016) by FDLI
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New to Food and Drug Law Group | Lunch Discussion: FDA Law and Marijuana by
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Open Payments Data and the Sunshine Act: Managing the Risk of Transparency 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

Update Magazine November/December 2015

December 2015

Features: Enforcement Eggs, Peanuts, and Adulterated Justice by Lynn Tyler and Kathleen Matsoukas................. 3 A Matter of Substant...

Update Magazine September/October 2015

September 2015

Letters Letter from the Editor by Judy Rein................................................................................................

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.......................

Policy Forums

Pure Powdered Caffeine: Stakeholders Take Measure of FDA’s Warning Letters

February 2016

FDLI’s first Food and Drug Policy Forum for 2016, guest-edited by Brenda Seidman, offers multistakeholder perspectives on...

What Food Laws Can the UK Adopt to Reduce Health Inequalities?

December 2015

In this issue of the Food and Drug Policy Forum British health researchers Stuart Flint and Sophia Reale review calorie and hea...

The Story and the Rest of the Story

November 2015

In “The Story and the Rest of the Story,” issue #10 of the Food and Drug Policy Forum’s 2015 edition, Peter Pitts and R...

Food and 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...

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program

January 2016

The 340B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discou...

A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance 70 FOOD AND DRUG LAW JOURNAL 453-480 (2015)

December 2015

After describing the historical development of China’s food safety system from the perspectives of legislation and administration, ...

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 ...