Medical Devices

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...

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 ...

The Regulation of Medical Devices in Canada

January 2015

Sara Zborovski, Partner, Davis LLP Andy Radhakant, Partner, Davis LLP Andrew Lord, Associate, Davis LLP Canada’s reg...

Articles

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...

Medical Device Color Additives: What’s All the Ruckus About?

January 2015

Volume 5 Issue 1 of the FDLI Policy Forum – Medical Device Color Additives Brenda Seidman, M.S., Ph.D., RAC, Principal, Seidman R...

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...

Food & Drug Law Journal

An Unfulfilled Promise: Changes Needed to the Drug Approval Process to Make Personalized Medicine a Reality, 70 Food and Drug Law Journal 289–314 (2015)

July 2015

The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recent...

A Tale of Two Transparency Attempts at FDA, 68 Food and Drug Law Journal, 423-449 (2013)

July 2015

This Article describes and evaluates two elements of the FDA’s recent operations implicating information transparency: the Transpar...

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...