Conference Papers

Session 1A: Drugs I


The History and Political Economy of the Hatch-Waxman Amendments, Erika Lietzan

The More Things Change: Improvement Patents, Drug Modifications, and the FDA, Dmitry Karshtedt

Session 1B: Food and Animal Products


Retooling American Foodralism, Laurie Beyranevand and Diana Winters

Administrative Guidance and Genetically Modified Food, Joanna Sax and Edward L. Rubin

Session 1C: Medical Products: Cross-Cutting Issues I


Can the Food Drug and Cosmetic Act Survive the 21st Century?, Ralph F. Hall

Regulating Intermediate Technologies, Rachel E. Sachs

Session 2A: Drugs II


Reversal of Fortune: Moving Pharmaceuticals from Over-the-Counter to Prescription Status?, Lars Noah

On Drugs: Renovating Preemption, Elizabeth Y. McCuskey

Session 2B: Medical Products: Cross-Cutting Issues II


21st Century Citizen Pharma: The FDA & Patient Focused Drug Development, Jordan Paradise

Non-Therapeutic Uses and the FDA, Patricia J. Zettler

Session 2C: Other FDA Product Areas: Tobacco and Cosmetics


Gender & the Inadequate Regulation of Cosmetics, Marie Boyd

Is the End of Smoking in Sight?: Tobacco Control in the Trump Years and Beyond, Micah L. Berman

Session 3A: Medical Devices


FDA’s Role in Governance of Black-Box Medicine, W. Nicholson Price II, JD, PhD

Digital Health and Regulatory Experimentation at the FDA, Nathan Cortez

Session 3B: Biological Products


Follow-On Biologics Are Set Up to Fail, Yaniv Heled

Improving Life Sciences Regulation: Solutions to the Current Impasse, Myrisha S. Lewis

Session 3C: Beyond Traditional Drug Regulation


Cannabis for Medical Use: FDA and DEA Regulation in the Hall of Mirrors, Rebecca S. Eisenberg and Deborah B. Leiderman

Drugs’ Other Side-Effects, Craig Konnoth