Bringing Your Pharmaceutical Drug to Market

Posted on April 2015 by Ralph Hall, Matt Hill, Neil Di Spirito

Written by the most experienced drug attorneys in the United States and edited by three distinguished authorities in the field, Bringing Your Pharmaceutical Drug to Market is one of the most compre...read more

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

Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition

Posted on September 2014 by Edited by Mark Carlisle Levy

Want to ensure that your company and clients meet the complicated FDA regulations for off-label advertising and promotion of pharmaceutical products? The fourth edition of FDLI’s best-sellin...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

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

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

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 This resource compiles statutes related to the Food, Drug, and Cosmetic Act (FDCA) that food and drug law practitioners are likely to encounter as they pr...read more

Pharmaceutical Risk Management

Posted on January 2008 by Jeffery E. Fetterman, Wayne L. Pines, Gary H. Slatko

Puzzled by REMS? We have the answer for you! Pharmaceutical Risk Management: Practical Applications With a Foreword by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and...read more

The Expert's Guide to Healthcare Product Due Diligence

Posted on August 2006 by Edited by Carl Osborne & Beth Silverstein

This book is intended to provide individuals responsible for and participating in the due diligence process of a healthcare product or product company with a framework and mindset for maximizing th...read more