“Should Oral Contraceptives Be Available Over the Counter?” is the timely topic addressed by Britt Whalin, AM (Director of Development and Communications), Kate Grindlay, MSc (Senior Pr...read more

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President and Chief Executive Officer Susan C. Winckler will step down ...read more

FDA’s Social Media Draft Guidance Is Focus of New FDLI Food and Drug Law Policy Forum

Posted on February 2014 by Davina Rosen Marano, Editor, FDLI

“Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?” is the timely topic addressed by Daniel Kracov, Partner, ...read more

“The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?” is the topic addressed by Karla L. Palmer...read more

The Food and Drug Law Institute To Honor Axelrad, Gibbs, Holcombe, Kingham

Posted on December 2013 by Michel Levin-Epstein, Editor-in-Chief, FDLI

Honorees Will Receive Distinguished Service and Leadership Awards at Holiday Reception December 10 December 5, Washington, DC -- The Food and Drug Law Institute will honor four outstanding food and...read more

“How Should FDA and Generic Drug Manufacturers’ Respond to FDA’s Proposed Changes to Generic Drug Labeling Rules?” is the topic addressed by Jane Bockus, Shareholder, Cox Sm...read more

“With Respect to New Molecular Entities with Abuse Potential, Should FDA’s Recommendations for Controlled Substances Act (CSA) Scheduling Be Immediately Effective upon FDA Approval?&rdq...read more

In this Policy Forum, Beakes-Read and Meyer focus on the increasingly lengthy controlled-substance-scheduling process for new molecular entities (NMEs).  The authors explain that the growing g...read more

“How Should FDA Implement a More Rational and Workable Approach to  Regulating Tobacco, Nicotine, and Alternative Harm Reduction Products?” is the topic addressed by Frank Dukes, P...read more

“Can FDA Accelerate Clinical Trial Timelines and Completion Using Documented cGMP Processes?” is the topic addressed by Anton Lewis Usala, M.D., President and CEO, CTMG, Inc. and Neil D...read more