Drugs

Books & Primers

A Practical Guide to FDA’s Food and Drug Law and Regulation -5th Edition

April 2014

A Practical Guide to Food and Drug Law and Regulation provides a basic introduction to the laws and regulations that govern the developme...

Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014

January 2014

Published for the fifth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug ca...

FDCA Statutory Supplement, 2013

December 2013

FDCA Statutory Supplement, 2013 Edited by Joy Liu, Esq Why spend countless hours trying to piece together recent amendments to the Feder...

Articles

Should Oral Contraceptives Be Available Over the Counter?

March 2014

Policy Forum – Oral Contraceptives to Over-the-Counter Status This issue of Policy Forum (Volume 4, Number 3, March 12, 2014) &ndas...

Over the Counter Status of Oral Contraceptives is Focus of New FDLI Food and Drug Law Policy Forum

March 2014

“Should Oral Contraceptives Be Available Over the Counter?” is the timely topic addressed by Britt Whalin, AM (Director of De...

Winckler to Step Down as FDLI President and CEO; Recruitment Underway

March 2014

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President a...

Food & Drug Law Journal

A Comparative Legal Analysis of Social Media Advertising of Drugs in Germany and the United States, 68 Food and Drug Law Journal, 259-279 (2013)

August 2013

Pharmaceutical companies use social media such as Facebook and Twitter more and more to advertise their products. Advertising of medicina...

Does Sackett Foreshadow the End of Non-Reviewability for FDA Warning Letters?, 68 Food and Drug Law Journal, 241-258 (2013).

August 2013

FDA warning letters are considered non-final agency actions and thus are not subject to judicial review under the Administrative Procedur...

America, You Are Digging Your Grave with Your Spoon—Should the FDA Tell You That on Food Labels?, 68 Food and Drug Law Journal, 309-327 (2013)

August 2013

R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA’s promulgation of graphic images violated tobacco com...