Food and Drug Policy Forum Volume 5, issue 7, 2015, August 19, 2015. Peter Huber and Paul Howard of the Manhattan Institute for Policy Research analyze the disjuncture between biomarker scienc...read more

Regulating Laboratory Developed Tests (LDTs)

Posted on March 2015 by Michelle Bayefsky,National Institutes of Health Department of Bioethics, Benjamin E. Berkman, National Institutes of Health Department of Bioethics

Volume 5 Issue 2 of the FDLI Policy Forum – Regulating Laboratory Developed Tests (LDTs) Michelle Bayefsky,National Institutes of Health Department of Bioethics, Benjamin E. Berkman, Nation...read more

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

Posted on December 2014 by Andrew Ittleman, Esq., Partner, Fuerst Ittleman David & Joseph, PL Jessika Tuazon, Esq., Associate, Fuerst Ittleman David & Joseph, PL

Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization? Andrew Ittleman, Esq., Partner, Fuerst Ittleman David & Joseph, PL Jessika Tuazon, Esq., Associate, Fuerst...read more

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 Promised Land?” focuses on how to best maximize the value...read more

Can Bayesian Extrapolation Improve FDA Regulation of Off-Label Uses of Drugs and Devices?

Posted on June 2014 by Ryan Abbott, Associate Professor of Law, Southwestern Law School and Visiting Assistant Professor of Medicine, David Geffen School of Medicine at UCLA Ian Ayres, William K. Townsend Professor, Yale Law School

In this Policy Forum, Authors Ryan Abbott and Ian Ayres explore the issue of extrapolation arising in the regulation of medicine. The authors note this extrapolation problem can arise when physicia...read more

Should Oral Contraceptives Be Available Over the Counter?

Posted on March 2014 by Britt Wahlin, AM, Director of Development and Communications, Ibis Reproductive Health Kate Grindlay, MSc, Senior Project Manager, Ibis Reproductive Health and Daniel Grossman, MD, Vice President of Research, Ibis Reproductive Health

Policy Forum – Oral Contraceptives to Over-the-Counter Status This issue of Policy Forum (Volume 4, Number 3, March 12, 2014) – Should Oral Contraceptives Be Available Over the Counter?...read more

Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?

Posted on February 2014 by Daniel A. Kracov, Partner, Abraham Gitterman, Associate, and Arnold & Porter, LLP

This issue of Policy Forum (Volume 4, Number 2, February 26, 2014) – Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ Abo...read more

What Are the Key Implementation Challenges in the Supply Chain Security Provisions of the Drug Quality and Security Act?

Posted on December 2013 by Vince Ventimiglia, Counsel, Health and Life Sciences Group, Faegre Baker Daniels and Eric Marshall, Associate, Health and Life Sciences Group, Faegre Baker Daniels

In this Policy Forum, Ventimiglia and Marshall provide a comprehensive overview of the drug supply chain security provisions of the Drug Quality and Security Act (DQSA) and explore three areas of i...read more

In this Policy Forum, Palmer discusses policy questions raised by the “Compounding Quality Act” or Title I of the recently enacted Drug Quality and Security Act (DQSA).  Specifical...read more

How Should FDA and Generic Drug Manufacturers’ Respond to FDA’s Proposed Changes to Generic Drug Labeling Rules?

Posted on November 2013 by Jane Bockus, Shareholder, Cox Smith and Francisco T. Rivas, Vice President, Compliance & Integrity Programs, NSF—Becker Consulting

In this Policy Forum, Bockus and Rivas explore the impact for generic manufacturers and for FDA of the proposed changes to FDA’s generic drug labeling rules.  The authors state that this...read more