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 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 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 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 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. & 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 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 more

Biomedical Software Regulation

Posted on April 2009 by Thomas E. Colonna and Jonathan S. Helfgott, Editors

As health care professionals increasingly rely on biomedical software to help treat patients, it is also becomingly increasingly complex. This book describes how the federal government is 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 more

FDA's Creative Application of the Law, 2nd Edition

Posted on August 2006 by Fred H. Degnan

This book examines FDA's use of the Federal Food, Drug, and Cosmetic Act as a regulatory tool for bringing about change to public health policy. Citing landmark initiatives, this book documents more