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
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
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?
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
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
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
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
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