Food and Drug Law
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.
Outcomes: Discuss the background of drug/device regulation in the U.S. and the structure of the FDA; Discuss basic terms used in drug pricing; Distinguish among drugs, devices, biologics, dietary supplements and food; Discuss FDA inspections and enforcement mechanisms; Discuss the various approval pathways for "new drugs," and regulation of over-the-counter drugs; Discuss FDA patent concepts and market exclusivities; Discuss the various approval pathways for devices; Describe FDA regulatory paradigm for biologics; Describe the process for the conduct of clinical investigations in humans of drugs and devices and identify common compliance issues arising in the context of these investigations; Discuss FDA regulations for ensuring quality and consistency (eg, GMP, GLP, QSR); Describe FDA's processes for post-market surveillance of drugs and devices, including recalls; Discuss FDA's labeling and advertising requirements, and understand interaction between FDA and FTC; Describe off-label promotion and the intersection of FDA promotional requirements with First Amendment law and the False Claims Act.
Outcomes: Discuss the background of drug/device regulation in the U.S. and the structure of the FDA; Discuss basic terms used in drug pricing; Distinguish among drugs, devices, biologics, dietary supplements and food; Discuss FDA inspections and enforcement mechanisms; Discuss the various approval pathways for "new drugs," and regulation of over-the-counter drugs; Discuss FDA patent concepts and market exclusivities; Discuss the various approval pathways for devices; Describe FDA regulatory paradigm for biologics; Describe the process for the conduct of clinical investigations in humans of drugs and devices and identify common compliance issues arising in the context of these investigations; Discuss FDA regulations for ensuring quality and consistency (eg, GMP, GLP, QSR); Describe FDA's processes for post-market surveillance of drugs and devices, including recalls; Discuss FDA's labeling and advertising requirements, and understand interaction between FDA and FTC; Describe off-label promotion and the intersection of FDA promotional requirements with First Amendment law and the False Claims Act.