Food and Drug Law and Regulation, 3rd Edition

Posted on March 2015 by David G. Adams, Richard M. Cooper, Martin J. Hahn & Jonathan S. Kahan, Editors

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in the field, Food and Drug Law and Regulation is one of the mo...read more

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

Posted on April 2014 by Edited by Wayne Pines and Ken Pina

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the development, marketing and sale of food, medical products, cosmetics ...read more

FDCA Statutory Supplement, 2013

Posted on December 2013 by Editor, Joy Liu, Esq

FDCA Statutory Supplement, 2013 Edited by Joy Liu, Esq Why spend countless hours trying to piece together recent amendments to the Federal Food, Drug, and Cosmetic Act (FDCA)? We’ve done the...read more

Bringing Your Medical Device to Market, 3rd Edition

Posted on April 2013 by John B. Reiss, Editor

Medical device companies face extraordinary obstacles to successfully develop and market a medical device. This practical, yet comprehensive, book is now in its third edition and is a must-have too...read more

Brazilian Drug and Medical Device Regulation: A Practical Guide

Posted on January 2013 by Edited by: Carlos T. Angulo and Areta L. Kupchyk

The Food and Drug Law Institute (FDLI) is pleased to provide Brazilian Drug and Medical Device Regulation: A Practical Guide as a companion product to our pioneering conference, U.S. & Brazil...read more

Pharmaceutical and Medical Device Compliance Manual, First Edition (FDLI)

Posted on November 2012 by Edited by Kathleen M. Boozang, J.D., LL.M and Simone Handler-Hutchinson, J.D.

Published by: American Health Lawyers Association (AHLA); Seton Hall; Food and Drug Law Institute (FDLI) The fight against fraud and abuse in healthcare programs, and the pharmaceutical and m...read more

PDUFA and the Expansion of FDA User Fees: Lessons from Negotiators

Posted on April 2011 by Nancy Bradish Myers and Anne Petruska McNIckle, Editors

Since passage of the first Prescription Drug User Fee Act almost 20 years ago, user fee negotiations and the legislative vehicles that authorize them have significantly changed the scope of FDA&rsq...read more

Using Social Media in FDA-Regulated Industries: The Essential Guide

Posted on September 2010 by Edited by Carrie C. Dooher

This useful guide includes chapters from FDA, FTC, marketing professionals, patient advocates, private attorneys and industry groups- it presents different issues and perspectives on the cutting ed...read more

Medical Device Regulation & Compliance

Posted on May 2010 by Stephen D. Terman and Neil F. O'Flaherty, Editors

This practical guidebook is one of the most comprehensive resources published in the often complicated field of medical device regulation and compliance. FDA has made it clear that it intends to be...read more

Compilation of FDCA-Related Food and Drug Laws, 2010 Edition

Posted on April 2010 by Deborah M. Shelton, Editor

Compilation of FDCA-Related Statutes, 2010 (Including Statutes Relating to Food and Medical Products; Regulation of Commerce; Enforcement and Criminal Sanctions; and Administrative Law) This valuab...read more