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