Resources



Primers

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

Books

Bringing Your Pharmaceutical Drug to Market by Ralph Hall, Matt Hill, Neil Di Spirito
view details

Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition by Edited by Mark Carlisle Levy
view details

Conferences

Dietary Supplements Enforcement: The New York Attorney General’s Actions and Jurisdictional Lines by FDLI
view details

State Regulation of Tobacco and Nicotine Products by FDLI
view details

What You Need to Know About the FSMA Final Rules: Preventive Controls for Human Food by FDLI
view details

Conference CDs

Introduction to Food Law and Regulation : Understanding How the Government Regulates the Food Industry – PowerPoint presentation with live audio by FDLI
view details

An Exploration of Ethical Issues Raised by Stevens, Stryker Biotech and Similar Cases Audio by
view details

2012 Annual Conference: Address from the Office of Chief Counsel, Former FDA Chief Counsels Roundtable Audio by
view details

Update Magazine

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...

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...

Policy Forums

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...

Should Food Businesses Be Able to Use the First Amendment to Resist Providing Consumers with Government-Mandated Public Health Messages?

April 2015

Should government-mandated food labeling ever be considered unconstitutional as impermissible “compelled speech”?  Steph...

Food and Drug Law Journal

Embracing 21st Century Information Sharing:Defining a New Paradigm for the Food and Drug Administration’s Regulation of Biopharmaceutical Company Communications with Healthcare Professionals, 70 Food and Drug Law Journal 143–160 (2015)

January 2015

The Food and Drug Administration (FDA) plays a unique role in protecting the public health and minimizing the risk of the distribution of...

Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA, 70 Food and Drug Law Journal 187–207 (2015)

January 2015

The Supreme Court’s decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a &ldq...

The End of “Patent Medicines”? Thoughts on the Rise of Regulatory Exclusivities, 70 Food and Drug Law Journal 39–54 (2015)

January 2015

Georgetown University Law Center: Reflections on Current Food and Drug Law Issues For this inaugural issue of the FDLI–Georgetown...

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 ...