Resources



Primers

The Regulation of Follow-on Biologics: FDA Authority and Implementation by Carolyne Hathaway, John Manthei, Elizabeth Richards and Eitan Bernstein
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FDA’s Regulation of Veterinary Drug Products by Hughes-Coons and Nobert
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Books

Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition by Edited by Mark Carlisle Levy
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A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition by Edited by Wayne Pines and Ken Pina
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Conferences

Food Safety: Latest FSMA Developments & Enforcement Actions in a Changing Business Climate by FDLI
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Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs by FDLI
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Advertising and Promotion Conference by FDLI
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Conference CDs

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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2012 Annual Conference: Working in the Food and Drug Law Space: Challenges and Opportunities Audio by
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Update Magazine

Members Only ContentSelf-Enforcement of Regulatory Compliance through a Culture of Credibility

November 2013

At the 2013 Food and Drug Law Institute’s Advertising and Promotion Conference in September, 2013, Mary Riordan from the Office of ...

Members Only ContentAttack on Multiple Fronts in Nutraceutical Marketing: The threat of FTC, FDA and Consumer Class Actions

November 2013

Nutraceutical products recently have been the subject of a multitude of class-action lawsuits questioning their marketing, efficacy, and ...

Members Only ContentMonitoring the Safety of Dietary Supplements and Novel Foods: Looking Beyond the Recent GAO Report

September 2013

Consumers worldwide are increasingly turning to dietary supplements, and the food industry is responding with an expanding diversity of p...

Policy Forums

The GRAS Exemption and GRAS Notification: Is There a Need for Significant Changes to Current Policy?

August 2014

Volume 4 Issue 7 of the FDLI Policy Forum – GRAS Issue 7 of the FDLI Policy Forum focuses on the generally recognized as safe (GRAS...

E-cigarettes: A life-saving technology or a way for tobacco companies to re-normalize smoking in American Society?

July 2014

This issue of Policy Forum, written by Joel Nitzkin, focuses on e-cigarettes and recommend adding a tobacco harm reduction component to t...

Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?

June 2014

In this Policy Forum, Authors Ryan Abbott and Ian Ayres explore the issue of extrapolation arising in the regulation of medicine. The aut...

Food and Drug Law Journal

Beyond Cheeseburgers: The Impact of Commonsense Consumption Acts on Future Obesity-Related Lawsuits, 68 Food and Drug Law Journal, 229-239 (2013).

August 2013

Since 2004, 25 states have passed Commonsense Consumption Acts (CCAs) to shield the food industry from civil liability for claims arising...

A Comparative Legal Analysis of Social Media Advertising of Drugs in Germany and the United States, 68 Food and Drug Law Journal, 259-279 (2013)

August 2013

Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicina...

Meet Your Meat: The Argument for Increasing Education and Public Outreach Regarding the Regulation and Safety of Animal Biotechnology, 68 Food and Drug Law Journal, 281-307 (2013)

August 2013

Biotechnology has evolved beyond the realm of child’s guess-and-check to a precise science, and now promises to help solve some of ...

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 ...