Seminar II: FDA Regulations

Catalog description

This course will give students a fundamental understanding of the regulatory framework governing the development and approval of pharmaceutical products. The course will cover the organizational structure and powers of the Food and Drug Administration (FDA) and the distinctive regulatory requirements for approval of new biologics, drugs, dietary supplements, and medical devices. There are six 1-credit-hour seminar courses to be taken in each semester of the freshman, sophomore, and junior years.