Drugs

Books & Primers

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

This primer is designed to be an introduction to food law and regulation. Food law is an ever-growing and ever-changing area of law and r...

Bringing Your Pharmaceutical Drug to Market

April 2015

Written by the most experienced drug attorneys in the United States and edited by three distinguished authorities in the field, Bringing ...

Food and Drug Law and Regulation, 3rd Edition

March 2015

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

Articles

Members Only ContentUpdate Magazine May/June 2015

July 2015

Table of Contents  (Coming soon)

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 ...

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...

Food & 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...