WORLD OF GENERIC DRUGS MODULE

Learning Objectives

Upon completion of the Overview of the Generic Drugs unit, you will be able to:

• Describe the roles and responsibilities of CDER's Office of Generic Drugs
• Describe where the responsibilities for patent protection reside
• Discuss the types of patent certification
• Explain the differences between the NDA and ANDA review processes
• Describe the generic drug review process
• List the communication tools used with ANDA holders
• Describe postmarketing
• Explain how FDA assures generic drug quality

Now that you understand the objectives we are trying to achieve, let's begin this unit.