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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Introduction to Drug Law and Regulation (May 2015) by FDLI
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Introduction to Medical Device Law and Regulation (June 2015) by FDLI
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Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries (2015) 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

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 Fight: An Examination of Recent Trends in Food Litigation and Where We Go From Here

April 2015

This special issue of the Food and Drug Law Institute’s Food and Drug Policy Forum brings together a series of short reflections on...

Regulating Laboratory Developed Tests (LDTs)

March 2015

Volume 5 Issue 2 of the FDLI Policy Forum – Regulating Laboratory Developed Tests (LDTs) Michelle Bayefsky,National Institutes of ...

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 ...


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 ...