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September 12, 2016, 5:00 PM

Presentation

Download the Presentation: Pharmaceutical Federalism

About the Presenter

Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration. Her research focuses on the interaction between state and federal regulation of medicine and science, the challenges that innovation poses for the FDA’s regulatory scheme, and the treatment use of experimental drugs and devices outside of clinical trials. Zettler’s scholarship has appeared or is forthcoming in various legal and medical journals, including the Indiana Law Journal, San Diego Law Review, Yale Journal of Health Policy Law and Ethics, Journal of Law and the Biosciences, Boston University International Law Journal, JAMA Internal Medicine, EMBO Molecular Medicine, and Academic Medicine. Zettler teaches Torts, Health Law: Quality & Access, and Food and Drug Law.

Before joining Georgia State Law in 2015, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. Prior to her fellowship, she served as an associate chief counsel in the FDA’s Office of Chief Counsel, where she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics and advisory committees.

In addition to her legal background, Zettler has several years of experience in bioethics. While in law school, she spent a semester in the National Institutes of Health Bioethics department conducting research on expanded access to investigational drugs. Before law school, she worked as a research assistant at the University of California San Francisco Medical Ethics program, focusing on ethical issues in human embryonic stem cell research and physician-patient communication. At UCSF, she also served as the coordinator of the Greenwall Faculty Scholars Program.

Zettler graduated with distinction from Stanford Law School in 2009. She received a BA in psychology, with distinction and departmental honors, from Stanford University in 2002.

Tags

biotechnology   clinical research   fda   health law policy   innovation   pharmaceuticals   regulation