This seminar examines the Food and Drug Administration as an administrative agency combining law and science to regulate activities affecting public health and safety. Topics include testing and approval of pharmaceuticals and medical devices; food safety and nutritional policy; biologics and biotechnology regulation; cosmetic regulation; pricing of and reimbursement for drugs and devices; global aspects of pharmaceutical regulation, US and foreign patent issues and FDA practice and procedure; jurisdiction and enforcement. A writing project involving research on food and drug issues will be required. Recommended Course: Administrative Law.
NOTE: This seminar satisfies the upper-class professional skills requirement.
A student who fails to attend the initial meeting of a seminar (designated by an (S) in the title), or to obtain permission to be absent from either the instructor or the Registrar, may be administratively dropped from the seminar. Students who are on a wait list for a seminar are required to attend the first seminar meeting to be considered for enrollment.
