The US Food and Drug Administration (FDA) is authorized to regulate food, drug, device, biologic, veterinary, cosmetic and tobacco products under the Food, Drug and Cosmetic (FD&C) Act. FDA uses this authority to promote 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 continuous reform by regulators and stakeholders. In addition, FDA regulation is an increasingly global concept in light of the expansion 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, prohibited acts under the FD&C Act and enforcement action that FDA may utilize 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.