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 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
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 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
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
About This Monograph Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year. The Food and Drug Admini...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 in...read more
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
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
FDA: Century Of Consumer Protection commemorates the 100th anniversary of the enactment of the 1906 Pure Food and Drugs Act. This spirited and unprecedented book is the only book commemorating the ...read more