OFFICE OF NEW DRUGS MODULE

Learning Objectives

Upon completion of the Biologics Review unit, you will be able to:

• Define biological products
• Explain the biologics review process
• List the biologic products that are regulated by CDER
• List the characteristics of biotechnology products
• Understand the differences between New Drug Applications (NDA) and Biologics License Applications (BLA)
• Describe the key conditions for approval when licensing biologics and BLA approvals

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