Food and Drug Law and Regulation, 3rd Edition

Posted on December 2014 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

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

Tobacco Regulation and Compliance: An Essential Resource

Posted on March 2012 by Azim Chowdhury, Editor

Released December 2011 FDLI’s first publication focused exclusively on tobacco, this book serves as an essential resource to stakeholders navigating the continually developing regulation of...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

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

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 FDA...read more