Drugs

Books & Primers

Food and Drug Law and Regulation, 3rd Edition

December 2014

Written by the most experienced food and drug attorneys in the United States and edited by four of the most distinguished authorities in ...

The Basics of Biostatistics in FDA Regulation – An FDLI Primer

November 2014

Instant Access, Purchase and Download Now By Coleen Klasmeier, Partner, Sidley Austin LLP; Ryan Kaat, Associate, Sidley Austin LLP Biosta...

Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition

September 2014

Want to ensure that your company and clients meet the complicated FDA regulations for off-label advertising and promotion of pharmaceutic...

Articles

Regulating Laboratory Developed Tests (LDTs)

March 2015

Volume 5 Issue 2 of the FDLI Policy Forum – Regulating Laboratory Developed Tests (LDTs) Michelle Bayefsky,National Institutes of ...

Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization?

December 2014

Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization? Andrew Ittleman, Esq., Partner, Fuerst Ittleman Da...

Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land?

November 2014

Issue 10 of the FDLI Food and Drug Policy Forum, entitled “Post-Market Drug Regulation in the Age of Big Data: What Path to the Pro...

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...