FDA Law and Regulation

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.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

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: 4–8 Hours
  • RAC Credits: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, participants should be able to:

  • 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

  • Lesson 1: FDA Overview
  • Lesson 2: Administrative Practice and Procedure
  • Lesson 3: Prohibited Acts and Enforcement
  • Lesson 4: Regulated Products
  • Lesson 5: Current Topics

Registration Options

This course is available for purchase as follows: