Regulation of Generic Drugs in the US

The generic regulatory environment is complex. This course organizes information provided by FDA and dives into greater detail for an immersive experience designed to bring new professionals up to speed and fill knowledge gaps for more experienced professionals. Learn about generics from the beginning of legislation to allow for legal generics to the current environment providing more efficient and competitive pathways for approval. This course provides a basic understanding of the legal and regulatory requirements for the marketing of generic drugs in the US. Topics to be covered include the concepts of bioequivalence and therapeutic equivalence, the role and mechanics of patents and non-patent market exclusivities, marketing applications, postapproval requirements and the new generic drug user fee requirements.

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

At A Glance

  • Target Audience: This course is designed for regulatory professionals and others in related departments interested in understanding the basics of generic drug regulation and approval in the US.
  • Learning LevelBasic
  • Total Length of Course: 3–6 Hours
  • RAC Credits: 3
  • Cost: Member $360; List $495
  • Format: PC and Tablet (iPad and Android)
  • Need more information? 
    View the RAPS Online University FAQs.

Learning Objectives

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

  • Describe the path to approval of an Abbreviated New Drug Application (ANDA)
  • Identify possible obstacles that might impede approval and explain the solutions for overcoming or avoiding such obstacles
  • Discuss responsibilities of applicants who obtain approval of a marketing application

Lesson Titles

  • Lesson 1: Basic Concepts
  • Lesson 2: ANDA Submission Process
  • Lesson 3: Postapproval ANDA Maintenance

Registration Options

This course is available for purchase as follows: