927: Food and Drug Law (Online)
This course will cover advanced topics in the law governing development and approval of devices, drugs, and biologics under the jurisdiction of the U.S. Food and Drug Administration. The course will review regulatory obligations for both manufacturers and providers conducting FDA-regulated clinical research. The course will also cover enforcement of non-compliance and how organizations develop compliance infrastructure to manage the highly detailed FDA regulations. LAW 958 is a preferred prerequisite but is not required.