FDLI’s first Food and Drug Policy Forum for 2016, guest-edited by Brenda Seidman, offers multistakeholder perspectives on FDA’s recent Warning Letters concerning bulk pure pow...read more

The Story and the Rest of the Story

Posted on November 2015 by Pitts and Goldberg

In “The Story and the Rest of the Story,” issue #10 of the Food and Drug Policy Forum’s 2015 edition, Peter Pitts and Robert Goldberg of the Center for Medicine in the Public Inte...read more

What Does the Future Hold for Patient-Focused Drug Development?

Posted on October 2015 by Nick Manetto, FaegreBD Consulting and David Zook, Faegre Baker Daniels

FDLI’s Food and Drug Policy Forum #9 (2015), “What Does the Future Hold for Patient-Focused Drug Development?” analyzes the emergence of PFDD as a critical componen...read more

Advancing More Predictive Preclinical Testing Tools

Posted on September 2015 by Elizabeth Baker, Tamara Drake, Robert Coleman, Kathy Archibald, and Katya Tsaioun

Food and Drug Policy Forum Volume 5, issue 8, 2015, September, 2015. How regulatory updates allowing for more modern test methods, pragmatic validation of preclinical test methods, and fda guidan...read more

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