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

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

A Practical Guide to FDA's Food and Drug Law and Regulation, 4th Edition

Posted on April 2012 by Kenneth R. Piña and Wayne L. Pines, Editors

The Fourth Edition of A Practical Guide to FDA's Food and Drug Law and Regulation updates and expands the widely-used Third Edition, including coverage of new laws on biosimilars, tobacco and food ...read more

Food and Drug Law and Regulation, 2nd Edition

Posted on December 2011 by David G. Adams, Richard M. Cooper, Martin J. Hahn & Jonathan S. Kahan, Editors

Food and Drug Law and Regulation is one of the most comprehensive guidebooks ever published covering an area that accounts for more than 25 percent of all consumer spending in the United States. Eq...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

Personalized Medicine: Prescriptions and Prospects

Posted on April 2011 by Joanne Hawana and Deborah Runkle, Editors

Personalized medicine means targeting the right treatment to the right patient. It encompasses pairing state-of-the-art diagnostics with drug development and raises issues related to bioethics, rei...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

FDCA Statutory Supplement and Compilation Combination

Posted on September 2010 by Joy J. Liu and Deborah M. Shelton, Editors

This new 2012 edition is fully updated to reflect the recent amendments to the Federal Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed in...read more