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
Published for the fourth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug cases of 2012, is written by more than two dozen recognized e...read more
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
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
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 i...read more
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 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
In an increasingly global economy, drug and device companies are learning the importance of bringing their business to China. Learn how to comply with Chinese standards with Compilation of Selected...read more
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
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