FDA Law and Regulation

This course provides an overview of FDA and its associated laws and regulations.

The US Food and Drug Administration (FDA) is authorized to regulate foods, dietary supplements, drugs, devices (including in vitro diagnostic), biologics, veterinary products, cosmetics and tobacco under the Food, Drug, and Cosmetic Act (FD&C Act). As stated in its mission statement, the agency uses this authority to help speed innovation of regulated products while protecting the public’s health by monitoring individuals and corporations for violations of the FD&C Act, and utilizing its tools of enforcement to rectify and prevent further violations. FDA regulation is subject to periodic reform by Congress and regulators, with input or challenges from other stakeholders. In addition, FDA regulation increasingly expands beyond US borders in light of the globalization of the supply chain for FDA-regulated products.

This course provides an overview of FDA and its associated laws and regulations. It discusses the history of FDA’s authority, compliance requirements for each category of regulated products, prohibited acts under the FD&C Act and actions that FDA may take when individuals or corporations violate the FD&C Act. This course also provides insight into FDA regulatory reform and the initiatives FDA is undertaking to create a globally harmonized regulatory scheme for food, drug, device and cosmetic products.

At a Glance

Target Audience: This course is designed for regulatory personnel and other individuals who are new to companies who manufacture products regulated by FDA.

Learning Level: Basic

Total Length of Course: 4 Hours

RAC Points: 4

Medical Device Certificate Elective

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Identify the organizational structure of FDA and its primary laws and regulations

Discuss the responsibilities and review processes of the centers responsible for each FDA-regulated products

Explain FDA’s source of authority, prohibited acts under the FD&C Act and available enforcement actions

Describe current reforms in the FDA arena and FDA’s global harmonization initiatives

Lesson Titles